FDA product code NLR: Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
NLR is the FDA product code for unit, electrosurgical, endoscopic (with or without accessories), reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under NLR. The average 510(k) review took 101 days (median 101).
Definition
This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NLR clearance
Top NLR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medisiss | 1 | 2003-07-03 |
Most recent NLR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030919 | Medisiss | SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES | 2003-07-03 | 101 |
Recalls for NLR devices
openFDA lists no recalls for product code NLR.
Frequently asked questions
What is FDA product code NLR?
NLR is the FDA product code for unit, electrosurgical, endoscopic (with or without accessories), reprocessed. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Gastroenterology and Urology panel.
What device class is NLR?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLR?
Across 1 cleared submissions the average was 101 days from receipt to decision (median 101).
Which companies have the most NLR clearances?
Medisiss (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NLR
- Run a recall and safety report across every NLR manufacturer
- Watch product code NLR 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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