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 Sterilmed, Inc., Ascent Healthcare Solutions and Vanguard Medical Concepts, Inc..

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
Cleared Oct 06, 2017
Reprocessed Ethicon Bladeless Trocars
K172097
Renovo, Inc.
Gastroenterology & Urology · 87d
Cleared Oct 05, 2017
Reprocessed Covidien Trocar
K172093
Renovo, Inc.
Gastroenterology & Urology · 86d
Cleared May 06, 2016
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
K160740
Surgical Instrument Service and Savings, Inc.
Gastroenterology & Urology · 50d
Cleared Apr 05, 2016
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
K153258
Surgical Instrument Service and Savings (Dba Medline Renewal
Gastroenterology & Urology · 147d
Cleared Jan 22, 2014
REPROCESSED CLOSURE SYSTEM
K133414
Sterilmed, Inc.
General & Plastic Surgery · 76d
Cleared Dec 31, 2013
REPROCESSED DILATING TIP TROCARS
K132629
Stryker Sustainability Solutions
Gastroenterology & Urology · 131d
Cleared Jun 11, 2012
REPROCESSED ENDOSCOPIC TROCARS
K121240
Sterilmed, Inc.
Gastroenterology & Urology · 48d
Cleared Jul 18, 2011
REPROCESSED ENDOSCOPIC TROCARS
K111002
Sterilmed, Inc.
Gastroenterology & Urology · 98d
Cleared Mar 19, 2010
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
K100080
Ascent Healthcare Solutions
Gastroenterology & Urology · 66d
Cleared Oct 15, 2007
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K063788
Ascent Healthcare Solutions
Gastroenterology & Urology · 298d
Cleared Oct 02, 2007
REPROCESSED TROCARS
K070059
Ascent Healthcare Solutions
Gastroenterology & Urology · 270d
Cleared Sep 07, 2007
NES REPROCESSED ENDOSCOPIC TROCAR
K060676
Northeast Scientific, Inc.
Gastroenterology & Urology · 542d
Cleared Jan 31, 2007
REPROCESSED TROCARS
K062497
Ascent Healthcare Solutions
Gastroenterology & Urology · 159d
Cleared Oct 11, 2006
VANGUARD REPROCESSED SUTURE PASSER
K053585
Ascent Healthcare Solutions
Gastroenterology & Urology · 292d
Cleared May 23, 2006
REPROCESSED ENDOSCOPIC TROCAR
K052299
Sterilmed, Inc.
Gastroenterology & Urology · 272d
Cleared May 23, 2005
REPROCESSED ENDOSCOPIC TROCAR
K043592
Sterilmed, Inc.
Gastroenterology & Urology · 145d
Cleared Apr 08, 2005
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
K043253
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 135d
Cleared Mar 31, 2005
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES
K043594
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 92d
Cleared Mar 04, 2003
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K024015
Alliance Medical Corp.
Gastroenterology & Urology · 90d
Cleared Nov 07, 2001
REPROCESSED ENDOSCOPIC TROCAR
K012578
Sterilmed, Inc.
Gastroenterology & Urology · 90d

About Product Code NLM - Regulatory Context