510(k) K160740
- Device
- Medline ReNewal Reprocessed ENDOPATH XCEL Trocar With OPTIVIEW Technology
- Applicant
- SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
- 510(k) number
- K160740
- Product code
- NLM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-05-06
- Date received
- 2016-03-17
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery, Reprocessed
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRANDI J. PANTELEON
- Address
- 2747 SW 6th St. Redmond OR US 97756 97756
FDA Registration Numbers#
- 3030153385
- 1061124
- 3035387162
- 1018470
- 1056128
- 3014023545
- 1417592
- 3032391
- 3013188547
- 1650907
- 3014461810
- 3020163307
- 3015453963
- 3011024991
- 3016761372
- 3021477808
- 3009350690
- 2011171
Source Documents#
Other 510(k) Records For Product Code NLM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201511 | Reprocessed Endoscopic Trocars and Sleeves | Stryker Sustainability Solutions | 2020-07-31 |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | Surgical Instrument Service and Savings, Inc. | 2019-04-15 |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves | Renovo, Inc. | 2017-10-06 |
| K172093 | Reprocessed Covidien Trocar | Renovo, Inc. | 2017-10-05 |
| K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars | Surgical Instrument Service and Savings (Dba Medline Renewal | 2016-04-05 |
| K133414 | REPROCESSED CLOSURE SYSTEM | Sterilmed, Inc. | 2014-01-22 |
| K132629 | REPROCESSED DILATING TIP TROCARS | Stryker Sustainability Solutions | 2013-12-31 |
| K121240 | REPROCESSED ENDOSCOPIC TROCARS | Sterilmed, Inc. | 2012-06-11 |
| K111002 | REPROCESSED ENDOSCOPIC TROCARS | Sterilmed, Inc. | 2011-07-18 |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | Ascent Healthcare Solutions | 2010-03-19 |
| K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | Ascent Healthcare Solutions | 2007-10-15 |
| K070059 | REPROCESSED TROCARS | Ascent Healthcare Solutions | 2007-10-02 |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | Northeast Scientific, Inc. | 2007-09-07 |
| K062497 | REPROCESSED TROCARS | Ascent Healthcare Solutions | 2007-01-31 |
| K053585 | VANGUARD REPROCESSED SUTURE PASSER | Ascent Healthcare Solutions | 2006-10-11 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases