Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Short answer: ENT (ear, nose and throat) surgical instruments are hand-held devices used in surgery on the ear, nose, sinuses, throat, larynx, trachea, bronchus and esophagus. In the United States the FDA lists them under one regulation, 21 CFR 874.4420, as Class I devices. Powered ENT drills are a separate, higher class. They are used by ENT surgeons and by operating-room, clinic and sterile-processing staff.
What ENT surgical instruments are
The FDA defines an “ear, nose, and throat manual surgical instrument” as “one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear” (21 CFR 874.4420(a), checked 2026-10-30). The definition covers a family of device types, not one product, so a single instrument tray can combine items from several of the groups below.
How the FDA defines and classifies them
Three regulations in 21 CFR Part 874, subpart E, cover most of what an ENT instrument set contains.
| Device group | Regulation | FDA class | What the regulation says |
|---|---|---|---|
| Manual ENT surgical instruments | 21 CFR 874.4420 | Class I, exempt from premarket notification subject to 874.9 | Generic type covering the named instruments listed in the next section |
| ENT bur | 21 CFR 874.4140 | Class I, exempt from premarket notification subject to 874.9 | An interchangeable drill bit for incising or removing bone in the ear, nose or throat area, with a carbide cutting tip or a diamond coating on a metal shank |
| ENT electric or pneumatic surgical drill | 21 CFR 874.4250 | Class II | A rotating drilling device, including the handpiece, that drives accessories such as an ENT bur |
The Class I exemption has limits. Under 21 CFR 874.9, the exemption does not apply when a device has a different intended use than a legally marketed device of that generic type, or when it “operates using a different fundamental scientific technology”; the regulation’s own example is a surgical instrument that cuts tissue with a laser beam rather than a sharpened metal blade (checked 2026-10-30).
Types of ENT manual instruments by anatomical site
The names below are the regulation’s own generic types. Grouping by site is an editorial arrangement for readability; the regulation lists the names without grouping.
| Site | Instrument types named in 21 CFR 874.4420 | Source |
|---|---|---|
| Airway: trachea, larynx, esophagus | Esophageal dilator, tracheal dilator, tracheal hook, tracheal bistoury (a long, narrow surgical knife), laryngeal injection set, laryngeal knife, laryngeal saw, laryngeal trocar, laryngectomy tube | 21 CFR 874.4420(a) |
| Mouth, tonsils and adenoids | Adenoid curette, adenotome, metal tongue depressor, mouth gag, oral screw, tonsillectome, tonsil guillotine, tonsil screw, tonsil snare, tonsil suction tube, tonsil suturing hook | 21 CFR 874.4420(a) |
| Nose and sinuses | Ethmoid curette, frontal sinus rasp, nasal curette, nasal rasp, nasal rongeur, nasal saw, nasal scissors, nasal snare, sinus irrigator, sinus trephine | 21 CFR 874.4420(a) |
| Ear | Ear curette, ear excavator, ear rasp, ear scissor, ear snare, ear spoon, ear suction tube, mastoid gauge, microsurgical ear chisel, myringotomy tube inserter, ossicle holding clamp, sacculotomy tack inserter, wire ear loop | 21 CFR 874.4420(a) |
| General ENT | Microrule, mirror, mobilizer, ENT punch, ENT knife, ENT trocar | 21 CFR 874.4420(a) |
For how individual instrument families work outside ENT, see the CASRAI guides to surgical scissors types, the speculum (including ear and nasal types), the laryngoscope and the tongue depressor.
Product codes: how the FDA database breaks the class down
The openFDA device classification database lists 89 product codes under regulation 874.4420, all device class 1 and reviewed by the Ear, Nose, and Throat panel (checked 2026-10-30). Product codes are the labels manufacturers and databases use to identify the exact sub-type. A few examples, using the database’s own names:
- KAI, Mirror, ENT; KAL, Retractor, ENT; KAE, Forceps, ENT; KAD, Elevator, ENT; KAK, Probe, ENT
- KBL, Depressor, Metal Tongue, Surgical; KBN, Gag, Mouth
- KBD, Scissors, Nasal; JZB, Scissors, Ear; KBB, Rongeur, Nasal; KAP, Curette, Nasal
- JYP, Knife, Myringotomy; JYM, Inserter, Myringotomy Tube; JYF, Clamp, Ossicle Holding
- MMO, Tray, Surgical, ENT, and OGR, Ear, Nose, and Throat Surgical Tray (the database notes OGR was established under the May 20, 1997 convenience-kits interim guidance)
- NLB, Trocar, Tracheal, Laryngeal, Sinus, Reprocessed; the database states that reprocessing validation data for this device type must be included in a 510(k) submission
Powered ENT devices: burs and drills
An ENT bur is the cutting tip; the drill is the powered handpiece that drives it. The bur regulation names mastoid surgery, frontal sinus surgery and surgery of the facial nerves as uses (21 CFR 874.4140). The bur is Class I and the powered drill is Class II (21 CFR 874.4250), which is why a set that combines manual instruments, burs and a drill spans two FDA classes. Other devices in the same subpart include the ENT fiberoptic light source and carrier (874.4350), bronchoscope (874.4680), nasopharyngoscope (874.4760) and otoscope (874.4770).
How to check an ENT instrument’s FDA status
The FDA sources above support three checks:
- Identify the regulation and product code of the instrument you are looking at. Manual instruments fall under 874.4420 (Class I); a powered drill falls under 874.4250 (Class II).
- Check whether the 874.9 limits apply. A different intended use or a different fundamental technology, such as a laser instead of a metal blade, takes a device outside the Class I exemption.
- For reprocessed items such as the NLB trocar code, the FDA database says reprocessing validation data belongs in the 510(k).
Safe use and handling basics
The CDC’s dental sterilization guidance (page dated May 15, 2024, checked 2026-10-30) is written for dental settings, not ENT, but states the general principle for instruments that enter tissue: “Critical items penetrate soft tissue or bone.” “These items have the highest risk of transmitting infections and should always be heat sterilized.” Cleaning is “the basic first step” in decontamination, and “unwrapped sterilization, sometimes called flash sterilization, is not a viable method” for routine use. Always follow the manufacturer’s instructions for use for the specific instrument. Related: washer-disinfectors.
Common mistakes
- Treating “ENT instrument” as one product. The regulation names dozens of generic types, and powered drills are in a different class from manual instruments.
- Assuming the Class I exemption is unconditional. 21 CFR 874.9 removes it for a new intended use or a different fundamental technology.
- Skipping cleaning because an item will be sterilized. CDC calls cleaning the basic first step.
- Relying on routine flash sterilization for critical items; the CDC dental guidance says it is not a viable routine method.
Related instrument guides
Other CASRAI guides cover ophthalmic surgical instruments and neurosurgical instruments, as well as dental and plastic surgery instruments.
FAQ
Are ENT manual surgical instruments regulated by the FDA?
Yes. They are a regulated generic device type under 21 CFR 874.4420, classified Class I (general controls) and exempt from premarket notification subject to 21 CFR 874.9.
What FDA class is an ENT surgical drill?
Class II under 21 CFR 874.4250. The bur it drives is Class I under 21 CFR 874.4140.
Do ENT surgical instruments need to be sterilized?
Instruments that penetrate soft tissue or bone are critical items, which the CDC’s dental guidance says should always be heat sterilized after cleaning. Follow the manufacturer’s instructions for use for each instrument.
Which instruments does the regulation name?
More than fifty generic types, from tonsil snares and mouth gags to nasal rongeurs and myringotomy tube inserters; see the table above.
Sources
- 21 CFR 874.4420, Ear, nose, and throat manual surgical instrument: law.cornell.edu/cfr/text/21/874.4420 (checked 2026-10-30)
- 21 CFR 874.4140, ENT bur: law.cornell.edu/cfr/text/21/874.4140 (checked 2026-10-30)
- 21 CFR 874.4250, ENT electric or pneumatic surgical drill: law.cornell.edu/cfr/text/21/874.4250 (checked 2026-10-30)
- 21 CFR 874.9, Limitations of exemptions: law.cornell.edu/cfr/text/21/874.9 (checked 2026-10-30)
- openFDA device classification API, regulation 874.4420: api.fda.gov device classification (checked 2026-10-30)
- CDC, Dental sterilization (May 15, 2024): cdc.gov dental sterilization (checked 2026-10-30)
