ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA— 510(k) K101794

Name: FDA 510(k) clearance K101794
Creator: U.S. Food and Drug Administration
Published: 2010-11-29

Substantially Equivalent

Advanced Surgical Concepts

FDA 510(k) clearance K101794 for ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA, Substantially Equivalent on 2010-11-29. Applicant: Advanced Surgical Concepts. Device class: 2.

Clearance details

Applicant: Advanced Surgical Concepts
Product code: Code OTJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2010-06-28
Decision date: 2010-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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