FDA product code NLY: Microdebrider, Ent, High Speed, Single Use, Reprocessed
NLY is the FDA product code for microdebrider, ent, high speed, single use, reprocessed. It is a Class I device, regulated under 21 CFR 874.4140 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under NLY. The average 510(k) review took 147 days (median 147).
Definition
ENT microdebrider is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nost and throat surgery. These devices operate at high speed for precise tissue resection. (this is for reprocessed sing use ENT microdebrider.)
Classification
| Field | Value |
|---|---|
| Device name | Microdebrider, Ent, High Speed, Single Use, Reprocessed |
| Device class | Class I |
| Regulation | 21 CFR 874.4140 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NLY clearance
Top NLY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medline Renewal | 1 | 2014-12-19 |
Most recent NLY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142022 | Medline Renewal | MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES | 2014-12-19 | 147 |
Recalls for NLY devices
openFDA lists no recalls for product code NLY.
Frequently asked questions
What is FDA product code NLY?
NLY is the FDA product code for microdebrider, ent, high speed, single use, reprocessed. It is a Class I device, regulated under 21 CFR 874.4140 and reviewed by the Ear, Nose and Throat panel.
What device class is NLY?
Class I, regulation 21 CFR 874.4140. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLY?
Across 1 cleared submissions the average was 147 days from receipt to decision (median 147).
Which companies have the most NLY clearances?
Medline Renewal (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NLY
- Run a recall and safety report across every NLY manufacturer
- Watch product code NLY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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