Laparoscope, General & Plastic Surgery, Reprocessed
FDA product code NLM · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
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).
23510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Sterilmed, Inc. 6
- Ascent Healthcare Solutions 5
- Vanguard Medical Concepts, Inc. 2
- Stryker Sustainability Solutions 2
- Surgical Instrument Service and Savings, Inc. 2
- Renovo, Inc. 2
- Surgical Instruments Service and Savings, Inc. 1
- Alliance Medical Corp. 1
- Northeast Scientific Inc. 1
- Surgical Instrument Service and Savings (Dba Medline Renewal 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201511 | Reprocessed Endoscopic Trocars and SleevesNLM · Traditional | Stryker Sustainability Solutions | 07/31/2020SE |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserNLM · Traditional | Surgical Instrument Service and Savings, Inc. | 04/15/2019SE |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesNLM · Traditional | Renovo, Inc. | 10/06/2017SE |
| K172093 | Reprocessed Covidien TrocarNLM · Traditional | Renovo, Inc. | 10/05/2017SE |
| K160740 | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW TechnologyNLM · Traditional | Surgical Instrument Service and Savings, Inc. | 05/06/2016SE |
| K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical TrocarsNLM · Traditional | Surgical Instrument Service and Savings (Dba… | 04/05/2016SE |
| K133414 | Reprocessed Closure SystemNLM · Traditional | Sterilmed, Inc. | 01/22/2014SE |
| K132629 | Reprocessed Dilating Tip TrocarsNLM · Traditional | Stryker Sustainability Solutions | 12/31/2013SE |
| K121240 | Reprocessed Endoscopic TrocarsNLM · Traditional | Sterilmed, Inc. | 06/11/2012SE |
| K111002 | Reprocessed Endoscopic TrocarsNLM · Traditional | Sterilmed, Inc. | 07/18/2011SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | Ascent Healthcare Solutions | 03/19/2010SE |
| K063788 | Reprocessed Endoscopic Trocars and CannulasNLM · Traditional | Ascent Healthcare Solutions | 10/15/2007SE |
| K070059 | Reprocessed TrocarsNLM · Traditional | Ascent Healthcare Solutions | 10/02/2007SE |
| K060676 | Nes Reprocessed Endoscopic TrocarNLM · Traditional | Northeast Scientific, Inc. | 09/07/2007SE |
| K062497 | Reprocessed TrocarsNLM · Traditional | Ascent Healthcare Solutions | 01/31/2007SE |
| K053585 | Vanguard Reprocessed Suture PasserNLM · Traditional | Ascent Healthcare Solutions | 10/11/2006SE |
| K052299 | Reprocessed Endoscopic TrocarNLM · Traditional | Sterilmed, Inc. | 05/23/2006SE |
| K043592 | Reprocessed Endoscopic TrocarNLM · Traditional | Sterilmed, Inc. | 05/23/2005SE |
| K043253 | Vanguard Reprocessed Dilating Tip and Blunt TrocarsNLM · Traditional | Vanguard Medical Concepts, Inc. | 04/08/2005SE |
| K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesNLM · Traditional | Vanguard Medical Concepts, Inc. | 03/31/2005SE |
| K024015 | Reprocessed Endoscopic Trocars and CannulasNLM · Traditional | Alliance Medical Corp. | 03/04/2003SE |
| K012644 | Reprocessed Trocars and CannulasNLM · Traditional | Surgical Instruments Service and Savings, Inc. | 07/29/2002SE |
| K012578 | Reprocessed Endoscopic TrocarNLM · Traditional | Sterilmed, Inc. | 11/07/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3187-2026 | REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3186-2026 | REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3185-2026 | REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3184-2026 | REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3183-2026 | REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &…Reusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3182-2026 | REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &…Reusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-0498-2019 Class II | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic…Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were… | Stryker Sustainability Solutions | 06/19/2018Terminated |
| Z-0765-2017 Class II | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars…An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the… | Stryker Sustainability Solutions | 11/11/2016Terminated |
| Z-2468-2015 Class II | Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve…Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704)… | Stryker Sustainability Solutions | 07/10/2015Terminated |
| Z-1836-2015 Class II | Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for…Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that… | Stryker Sustainability Solutions | 06/01/2015Terminated |
| Z-1835-2015 Class II | Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated…Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that… | Stryker Sustainability Solutions | 06/01/2015Terminated |
| Z-1834-2015 Class II | Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for…Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that… | Stryker Sustainability Solutions | 06/01/2015Terminated |
| Z-1630-2015 Class II | Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic…The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have… | CooperSurgical, Inc. | 03/20/2015Terminated |
| Z-1643-2013 Class II | - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |
| Z-2635-2010 | Enseal TRIO Product Code ETRIO335H, Lot Code: G4TC14, Exp. Date 2012/05The weld that connects the electrode to the active rod was separated. This connection is critical to the… | Ethicon Endo-Surgery Inc | 07/09/2010Terminated |
| Z-1674-2008 | Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety… | Ascent Healthcare Solutions, Inc. | 03/11/2008Terminated |
| Z-0414-2007 | AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available…The tip of the trocars may separate before and while in use. In some instances the trocars have been found… | Ascent Healthcare Solutions, Inc. | 10/19/2006Terminated |