FDA product code NLM: Laparoscope, General & Plastic Surgery, Reprocessed
NLM is the FDA product code for laparoscope, general & plastic surgery, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 23 510(k) submissions under NLM, from 10 different applicants. The average 510(k) review took 164 days (median 131). FDA has posted 18 recalls for NLM devices, 6 initiated in the last five years.
Definition
The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. 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 | Laparoscope, General & Plastic Surgery, Reprocessed |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NLM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 86 |
| 2019 | 1 | 192 |
| 2020 | 1 | 56 |
Compare with all 510(k) review times · Search every NLM clearance
Top NLM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sterilmed, Inc. | 6 | 2014-01-22 |
| Ascent Healthcare Solutions | 5 | 2010-03-19 |
| Stryker Sustainability Solutions | 2 | 2020-07-31 |
| Surgical Instrument Service and Savings, Inc. | 2 | 2019-04-15 |
| Renovo, Inc. | 2 | 2017-10-06 |
5 more applicants have NLM clearances. See the full list in Caduvo.
Most recent NLM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201511 | Stryker Sustainability Solutions | Reprocessed Endoscopic Trocars and Sleeves | 2020-07-31 | 56 |
| K182828 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | 2019-04-15 | 192 |
| K172097 | Renovo, Inc. | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | 2017-10-06 | 87 |
| K172093 | Renovo, Inc. | Reprocessed Covidien Trocar | 2017-10-05 | 86 |
| K160740 | Surgical Instrument Service and Savings, Inc. | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology | 2016-05-06 | 50 |
Recalls for NLM devices
18 product recalls in 11 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-08-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2026 | 6 |
Frequently asked questions
What is FDA product code NLM?
NLM is the FDA product code for laparoscope, general & plastic surgery, reprocessed. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NLM?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NLM?
Across 23 cleared submissions the average was 164 days from receipt to decision (median 131).
Which companies have the most NLM clearances?
Sterilmed, Inc. (6); Ascent Healthcare Solutions (5); Stryker Sustainability Solutions (2); Surgical Instrument Service and Savings, Inc. (2); Renovo, Inc. (2).
Have NLM devices been recalled?
Yes: 18 product recalls across 11 recall events; the most recent began 2026-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code NLM
- Run a recall and safety report across every NLM manufacturer
- Watch product code NLM 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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