NLM · Class II · 21 CFR 876.1500

FDA Product Code NLM: Laparoscope, General & Plastic Surgery, Reprocessed

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).

Leading manufacturers include Surgical Instrument Service and Savings, Inc. and Stryker Sustainability Solutions.

23
Total
23
Cleared
164d
Avg days
2001
Since

FDA 510(k) Cleared Laparoscope, General & Plastic Surgery, Reprocessed Devices (Product Code NLM)

23 devices
1–23 of 23
Cleared Jul 31, 2020
Reprocessed Endoscopic Trocars and Sleeves
K201511
Stryker Sustainability Solutions
General & Plastic Surgery · 56d
Cleared Apr 15, 2019
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
K182828
Surgical Instrument Service and Savings, Inc.
General & Plastic Surgery · 192d

About Product Code NLM - Regulatory Context