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Short answer: An adenoid curette is a hand-held manual surgical instrument for cutting and excising adenoid tissue. In the United States it is a Class I ear, nose, and throat manual surgical instrument under 21 CFR 874.4420 with its own FDA product code, KBJ (“Curette, Adenoid”), separate from the adenotome (KBH). This page is general product and regulatory information, not medical advice.
Definition and scope
The Global Medical Device Nomenclature (GMDN) term in the NLM AccessGUDID database for a reusable adenoid curette describes it as “a hand-held manual surgical instrument designed for cutting and excising adenoid tissue” (record checked 2026-10-30). The instrument belongs to the family of ENT hand instruments covered in our guide to ENT surgical instruments.
This page covers what the instrument is called, how FDA classifies it, and what its device records say. It does not describe how any procedure is performed, and nothing here replaces the judgement of a clinician or the manufacturer’s instructions for use.
How the instrument is described in practice
Device records identify an adenoid curette by its function, a manual cutting and excising tool, and by supplier details such as size and whether the instrument is reusable. One AccessGUDID record (a size 2 Barnhill Adenoid Curette, device identifier 00192896113800) lists the following, checked 2026-10-30:
- GMDN term “Adenoid curette, reusable”; the record is not marked single-use.
- Not packaged sterile; the record states it requires sterilization before use, and lists dry heat and moist heat (steam) as the sterilization methods.
- FDA product code KBJ, “Curette, Adenoid”.
- The labeling does not contain MRI safety information.
These are the attributes of that single record, not of every adenoid curette; each manufacturer publishes its own record and instructions for use.
Adenoid curette, adenotome, tonsil guillotine and tonsil snare
All four names appear in the same regulation. 21 CFR 874.4420(a) defines an ear, nose, and throat manual surgical instrument as one of a variety of devices for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear, and its list of generic types includes the adenoid curette, adenotome, tonsil guillotine and tonsil snare (eCFR, checked 2026-10-30).
| Instrument name | Named in 21 CFR 874.4420(a) | FDA product code and name |
|---|---|---|
| Adenoid curette | Yes | KBJ, “Curette, Adenoid” |
| Adenotome | Yes | KBH, “Adenotome” |
| Tonsil guillotine | Yes | KBO, “Guillotine, Tonsil” |
| Tonsil snare | Yes | KBZ, “Snare, Tonsil” |
Source for codes: openFDA device classification API and the FDA Product Classification Database, checked 2026-10-30. All four coded entries are Class I under regulation number 874.4420.
Where it matters for labs, clinics and supply records
For anyone maintaining an instrument catalogue or checking a supplier listing, the classification record gives a short checklist, each item traceable to FDA:
- Class I, general controls. 21 CFR 874.4420(b) classifies these instruments as Class I and exempts them from the premarket notification (510(k)) procedures, subject to the limitations in 21 CFR 874.9.
- Exempt from 510(k) is not exempt from everything. FDA’s product classification entry for KBH lists the 510(k) exemption as yes but good manufacturing practice exemption as no, and FDA’s page notes that exempt devices still require establishment registration. See our entry on FDA-registered establishments.
- Use the right product code. A curette is coded KBJ and an adenotome KBH.
- Check the reprocessing status. The device record states whether an instrument is reusable or single-use and whether it ships sterile; reusable instruments supplied non-sterile list the sterilization methods they name.
- Look up the device identifier. AccessGUDID records show the product code, GMDN term and labeling attributes for a given device identifier.
For the wider definition of a medical device and how adverse events are reported, see What is a medical device? and medical device reporting (MDR).
Common misunderstandings
“An adenoid curette and an adenotome are the same thing.”
They are separate generic types in 21 CFR 874.4420(a) and carry separate FDA product codes, KBJ and KBH. The regulation lists them together because it classifies the whole family of ENT manual instruments as one device type.
“Class I means no FDA requirements.”
Class I devices are subject to general controls. The FDA entry shows the product codes are not exempt from good manufacturing practice requirements, and the regulation’s exemption is limited by 21 CFR 874.9.
“Every instrument with this name is supplied sterile.”
Not so. The AccessGUDID record cited on this page describes a reusable instrument supplied non-sterile. Sterility and single-use status are per-product attributes in the device record.
FAQ
What is an adenoid curette used for?
The GMDN definition in AccessGUDID describes it as a hand-held manual surgical instrument designed for cutting and excising adenoid tissue. How and when it is used is a clinical decision for a qualified surgeon.
How does FDA classify an adenoid curette?
As a Class I device under 21 CFR 874.4420, product code KBJ, exempt from 510(k) subject to 21 CFR 874.9 (eCFR and openFDA, checked 2026-10-30).
Is an adenoid curette reusable?
The AccessGUDID record cited on this page lists a reusable instrument supplied non-sterile, with dry heat and moist heat sterilization methods. Other products may differ, so the manufacturer’s record and instructions for use govern.
Sources
- eCFR, 21 CFR 874.4420, Ear, nose, and throat manual surgical instrument: ecfr.gov (checked 2026-10-30).
- FDA Product Classification Database, product code KBH: accessdata.fda.gov (checked 2026-10-30).
- openFDA device classification API, regulation number 874.4420 (codes KBH, KBJ, KBO): open.fda.gov (checked 2026-10-30).
- NLM AccessGUDID, device identifier 00192896113800: accessgudid.nlm.nih.gov (checked 2026-10-30).
