NLM — Laparoscope, General & Plastic Surgery, Reprocessed Class II
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 |