ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE— 510(k) K110004

Name: FDA 510(k) clearance K110004
Creator: U.S. Food and Drug Administration
Published: 2011-01-26

Substantially Equivalent

Advanced Surgical Concepts

FDA 510(k) clearance K110004 for ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE, Substantially Equivalent on 2011-01-26. 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: 2011-01-03
Decision date: 2011-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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