NLMClass II

Laparoscope, General & Plastic Surgery, Reprocessed

21 CFR 876.1500 / Gastroenterology, Urology

NLM is the FDA product code for Laparoscope, General & Plastic Surgery, Reprocessed, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 23 510(k) clearances under this code, the most recent dated 2020-07-31, and 12 recalls.

Classification record

Product code: NLM
Device name: Laparoscope, General & Plastic Surgery, Reprocessed
FDA 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).
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 23
Ingested recalls: 18

Clearances, product code NLM

By decision year

23 clearances under product code NLM with a decision year between 2001 and 2020, 2007 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code NLM by decision year
Year	Clearances
2001	1
2002	1
2003	1
2005	3
2006	2
2007	4
2010	1
2011	1
2012	1
2013	1
2014	1
2016	2
2017	2
2019	1
2020	1

Applicants with the most clearances

Product code NLM

Applicants holding the most 510(k) clearances under product code NLM
Applicant	Clearances
Stryker Sustainability Solutions	9
Sterilmed Inc	6
ReNovo, Inc.	2
Medline ReNewal	2
Alliance Medical Corp.	1
Northeast Scientific Inc.	1
Surgical Instrument Service and Savings (dba Medline Renewal	1
Surgical Instruments Service and Savings, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order