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General product and regulatory information for laboratory, clinic and supply staff. This page is not medical advice and does not describe how any procedure is performed.
Short answer
A microdebrider is a powered ear, nose and throat (ENT) surgical instrument that FDA describes as an accessory to an ENT drill system, intended to remove soft and hard tissue during ear, nose and throat surgery. Under FDA’s product codes the drill system is Class II (21 CFR 874.4250), while ENT burs and reprocessed single-use microdebriders are Class I (21 CFR 874.4140).
Definition and scope
FDA’s product classification database has a product code titled "Microdebrider, ENT, High Speed, Single Use, Reprocessed" (code NLY). FDA’s definition for that code says an ENT microdebrider is an accessory to an ENT drill system, intended to remove soft and hard tissue during ear, nose and throat surgery, and that these devices operate at high speed. The record notes that the code is for reprocessed single-use ENT microdebriders, so it describes one slice of the market rather than every microdebrider.
The word is also used for sinus-specific products. The FDA 510(k) database lists, for example, the "Celeris, Disposable Sinus Debrider" from Gyrus ACMI (K212650, decision date 2022-01-19). Both naming styles point to the same ENT device family, not to separate regulatory categories.
What is a microdebrider used for?
The only use statement in FDA’s classification record for code NLY is the one above: removal of soft and hard tissue in ear, nose and throat surgery. This page does not cover operating technique. Surgical use is governed by the manufacturer’s instructions for use and by the operating clinician.
How the regulations describe the system
Two regulations in 21 CFR Part 874 (Ear, Nose, and Throat Devices) explain how a microdebrider fits into FDA’s framework.
- 21 CFR 874.4250 defines an ENT electric or pneumatic surgical drill as "a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area." Classification: Class II.
- 21 CFR 874.4140 defines an ENT bur as an interchangeable drill bit for that drill, consisting of a carbide cutting tip or a diamond coating on a metal shank, used in mastoid surgery, frontal sinus surgery and surgery of the facial nerves. Classification: Class I (general controls), exempt from premarket notification subject to the limitations in 21 CFR 874.9.
FDA’s NLY record places the reprocessed single-use microdebrider under the 874.4140 regulation as Class I, which is how the microdebrider gets tied to the drill-and-bur framework.
Which FDA code applies to which part
The table below maps each component family to the code and regulation in FDA’s own records (FDA classification data and the CFR text, checked 2026-10-30). It is the quickest way to avoid mixing up the three codes that are often confused.
| Component family | FDA product code and name | Regulation | Class |
|---|---|---|---|
| Drill system including handpiece | ERL, Drill, Surgical, ENT (Electric or Pneumatic) Including Handpiece | 21 CFR 874.4250 | II |
| ENT bur | EQJ, Bur, Ear, Nose and Throat | 21 CFR 874.4140 | I |
| Reprocessed single-use microdebrider | NLY, Microdebrider, ENT, High Speed, Single Use, Reprocessed | 21 CFR 874.4140 | I |
Where it matters for labs, clinics and supply decisions
For anyone cataloguing or documenting ENT surgical equipment, the practical point is that one product name can sit under more than one regulatory entry. FDA’s 510(k) records list several named microdebrider systems under product code ERL (the drill code), including the Stryker ESSx Microdebrider System (K073633, decision date 2008-08-26) and the 3.3 mm and 4.0 mm Laurimed Microdebrider (K163247, decision date 2017-03-09). A reprocessed single-use unit is instead recorded under NLY. A catalogue or asset record that stores only one regulation number can therefore be incomplete.
A checklist built only from the records above:
- Record the product code and regulation number from the manufacturer’s labeling or the FDA record, not from the product name alone.
- Note whether the item is a drill or handpiece (874.4250), a bur (874.4140) or a reprocessed single-use microdebrider (NLY, 874.4140), because the class differs.
- Follow the manufacturer’s instructions for use for compatibility between handpiece and accessories; the regulations only say the drill drives accessories.
Common misunderstandings
It is not an arthroscopic shaver
Shavers used in joint surgery are a different kind of device. See the arthroscopic shaver guide for joint-surgery shavers.
21 CFR 874.4140 is not the whole story
That regulation is titled "Ear, nose, and throat bur." It is the home of the NLY reprocessed microdebrider code, but the drill system that drives a microdebrider is classified under 874.4250.
A "microdebrider" in a record name does not guarantee product code ERL
The FDA 510(k) record K140521 for the Topaz EZ Microdebrider Coblation Wand (ArthroCare, decision date 2014-06-10) lists product code GEI, not ERL. Check the code on the specific record.
Related pages
For background on the specialty, see what otolaryngology is; for another surgical instrument classified in the same way, the trephine guide; for how clearance works, see the FDA 510(k) premarket notification guide and 510(k) vs PMA.
Frequently asked questions
What is a microdebrider?
FDA’s record for product code NLY describes an ENT microdebrider as an accessory to an ENT drill system that is intended to remove soft and hard tissue during ear, nose and throat surgery.
Which FDA class is a microdebrider?
It depends on the record. The ENT drill system including handpiece (code ERL, 21 CFR 874.4250) is Class II, while the ENT bur (EQJ) and the reprocessed single-use microdebrider (NLY), both under 21 CFR 874.4140, are Class I.
Is a microdebrider the same as an arthroscopic shaver?
No. Arthroscopic shavers are used in joint surgery and are covered in the arthroscopic shaver guide.
Sources
All sources below were checked on 2026-10-30.
- FDA Product Classification, code NLY (reprocessed single-use ENT microdebrider): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NLY
- FDA Product Classification, code ERL (ENT drill including handpiece): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=ERL
- 21 CFR 874.4140, Ear, nose, and throat bur: https://www.law.cornell.edu/cfr/text/21/874.4140
- 21 CFR 874.4250, Ear, nose, and throat electric or pneumatic surgical drill: https://www.law.cornell.edu/cfr/text/21/874.4250
- FDA 510(k) records K073633, K163247, K212650 and K140521 via openFDA: https://api.fda.gov/device/510k.json?search=device_name:microdebrider
