Laparoscope, General & Plastic Surgery, Reprocessed
The Reprocessed General and Plastic Surgery Laparoscope is a reprocessed endoscopic device intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals during laparoscopic surgical procedures; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NLM and regulation 21 CFR 876.1500 in the Gastroenterology and Urology specialty. The device is not an implant and is not life-sustaining.
Research product code NLM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NLM
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201511 | Reprocessed Endoscopic Trocars and Sleeves | Jul 31, 2020 | Substantially Equivalent | Stryker Sustainability Solutions |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | Apr 15, 2019 | Substantially Equivalent | Surgical Instrument Service and Savings, Inc. |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | Oct 06, 2017 | Substantially Equivalent | Renovo, Inc. |
| K172093 | Reprocessed Covidien Trocar | Oct 05, 2017 | Substantially Equivalent | Renovo, Inc. |
| K160740 | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology | May 06, 2016 | Substantially Equivalent | Surgical Instrument Service and Savings, Inc. |
| K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars | Apr 05, 2016 | Substantially Equivalent | Surgical Instrument Service and Savings (Dba Medline Renewal |
| K133414 | REPROCESSED CLOSURE SYSTEM | Jan 22, 2014 | Substantially Equivalent | Sterilmed, Inc. |
| K132629 | REPROCESSED DILATING TIP TROCARS | Dec 31, 2013 | Substantially Equivalent | Stryker Sustainability Solutions |
| K121240 | REPROCESSED ENDOSCOPIC TROCARS | Jun 11, 2012 | Substantially Equivalent | Sterilmed, Inc. |
| K111002 | REPROCESSED ENDOSCOPIC TROCARS | Jul 18, 2011 | Substantially Equivalent | Sterilmed, Inc. |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | Mar 19, 2010 | Substantially Equivalent | Ascent Healthcare Solutions |
| K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | Oct 15, 2007 | Substantially Equivalent | Ascent Healthcare Solutions |
| K070059 | REPROCESSED TROCARS | Oct 02, 2007 | Substantially Equivalent | Ascent Healthcare Solutions |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | Sep 07, 2007 | Substantially Equivalent | Northeast Scientific, Inc. |
| K062497 | REPROCESSED TROCARS | Jan 31, 2007 | Substantially Equivalent | Ascent Healthcare Solutions |
| K053585 | VANGUARD REPROCESSED SUTURE PASSER | Oct 11, 2006 | Substantially Equivalent | Ascent Healthcare Solutions |
| K052299 | REPROCESSED ENDOSCOPIC TROCAR | May 23, 2006 | Substantially Equivalent | Sterilmed, Inc. |
| K043592 | REPROCESSED ENDOSCOPIC TROCAR | May 23, 2005 | Substantially Equivalent | Sterilmed, Inc. |
| K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | Apr 08, 2005 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |
| K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES | Mar 31, 2005 | Substantially Equivalent | Vanguard Medical Concepts, Inc. |
| K024015 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | Mar 04, 2003 | Substantially Equivalent | Alliance Medical Corp. |
| K012644 | REPROCESSED TROCARS AND CANNULAS | Jul 29, 2002 | Substantially Equivalent | Surgical Instruments Service and Savings, Inc. |
| K012578 | REPROCESSED ENDOSCOPIC TROCAR | Nov 07, 2001 | Substantially Equivalent | Sterilmed, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.