Vanguard Reprocessed Suture Passer
FDA 510(k) K053585 · Ascent Healthcare Solutions
510(k) numberK053585
Submission
- Device name
- Vanguard Reprocessed Suture Passer
- Applicant
- Ascent Healthcare Solutions
Phoenix, AZ, US - Received
- December 23, 2005
- Decision date
- October 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLM – Laparoscope, General & Plastic Surgery, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- 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…
Other 510(k)s with product code NLM
| 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 |
More from Sterilmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111600 | Reprocessed Hand Activate Sealer/DividerNUJ · Traditional | 11/15/2011SE |
| K110189 | Reprocessed Electrosurgical InstrumentNUJ · Traditional | 07/18/2011SE |
| K100909 | Reprocessed Compression SleevesJOW · Traditional | 07/23/2010SE |
| K100254 | Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional | 05/28/2010SE |
| K100537 | Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional | 05/12/2010SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | 03/19/2010SE |
| K093702 | Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional | 03/04/2010SE |
| K092425 | Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional | 10/21/2009SE |
| K090323 | Reprocessed Electrophysiology CathetersNLH · Traditional | 04/01/2009SE |
| K082023 | Reprocessed Electrophysiology CathetersNLH · Traditional | 09/16/2008SE |
Questions and answers
When was Vanguard Reprocessed Suture Passer cleared by the FDA?
Vanguard Reprocessed Suture Passer (K053585) received a 510(k) decision of Substantially Equivalent on October 11, 2006, 292 days after the submission was received.
What is the product code of K053585?
The FDA product code is NLM – Laparoscope, General & Plastic Surgery, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 876.1500.