NLM — Laparoscope, General & Plastic Surgery, Reprocessed Class II
FDA product code NLM covers "Laparoscope, General & Plastic Surgery, Reprocessed", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NLM
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201511 | stryker sustainability solutions | Reprocessed Endoscopic Trocars and Sleeves | July 31, 2020 |
| K182828 | surgical instrument service and savings | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | April 15, 2019 |
| K172097 | renovo | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Slee | October 6, 2017 |
| K172093 | renovo | Reprocessed Covidien Trocar | October 5, 2017 |
| K160740 | surgical instrument service and savings | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology | May 6, 2016 |
| K153258 | surgical instrument service and savings (dba medline renewal | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars | April 5, 2016 |
| K133414 | sterilmed | REPROCESSED CLOSURE SYSTEM | January 22, 2014 |
| K132629 | stryker sustainability solutions | REPROCESSED DILATING TIP TROCARS | December 31, 2013 |
| K121240 | sterilmed | REPROCESSED ENDOSCOPIC TROCARS | June 11, 2012 |
| K111002 | sterilmed | REPROCESSED ENDOSCOPIC TROCARS | July 18, 2011 |
| K100080 | ascent healthcare solutions | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | March 19, 2010 |
| K063788 | ascent healthcare solutions | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | October 15, 2007 |
| K070059 | ascent healthcare solutions | REPROCESSED TROCARS | October 2, 2007 |
| K060676 | northeast scientific | NES REPROCESSED ENDOSCOPIC TROCAR | September 7, 2007 |
| K062497 | ascent healthcare solutions | REPROCESSED TROCARS | January 31, 2007 |
| K053585 | ascent healthcare solutions | VANGUARD REPROCESSED SUTURE PASSER | October 11, 2006 |
| K052299 | sterilmed | REPROCESSED ENDOSCOPIC TROCAR | May 23, 2006 |
| K043592 | sterilmed | REPROCESSED ENDOSCOPIC TROCAR | May 23, 2005 |
| K043253 | vanguard medical concepts | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | April 8, 2005 |
| K043594 | vanguard medical concepts | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES | March 31, 2005 |