COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003— 510(k) K090485

Name: FDA 510(k) clearance K090485
Creator: U.S. Food and Drug Administration
Published: 2009-07-22

Substantially Equivalent

Percutaneous Systems, Incorporated

FDA 510(k) clearance K090485 for COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003, Substantially Equivalent on 2009-07-22. Applicant: Percutaneous Systems, Incorporated. Device class: 2.

Clearance details

Applicant: Percutaneous Systems, Incorporated
Product code: Code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2009-02-25
Decision date: 2009-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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