VANGUARD REPROCESSED SUTURE PASSER— 510(k) K053585
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K053585 for VANGUARD REPROCESSED SUTURE PASSER, Substantially Equivalent on 2006-10-11. Applicant: Ascent Healthcare Solutions. Device class: 2.
Clearance details
- Applicant
- Ascent Healthcare Solutions
- Product code
- Code NLM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code NLM
view all- K201511 — Reprocessed Endoscopic Trocars and Sleeves
- K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
- K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
- K172093 — Reprocessed Covidien Trocar
- K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
More clearances from Ascent Healthcare Solutions
view all- K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER
- K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT
- K100909 — REPROCESSED COMPRESSION SLEEVES
- K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
- K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
Data sourced from openFDA. This site is unofficial and independent of the FDA.