UPDATED SLIP UROLOGY INTRODUCER SHEATH— 510(k) K042531

Name: FDA 510(k) clearance K042531
Creator: U.S. Food and Drug Administration
Published: 2005-02-01

Substantially Equivalent

Percutaneous Systems, Incorporated

FDA 510(k) clearance K042531 for UPDATED SLIP UROLOGY INTRODUCER SHEATH, Substantially Equivalent on 2005-02-01. Applicant: Percutaneous Systems, Incorporated. Device class: 2.

Clearance details

Applicant: Percutaneous Systems, Incorporated
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2004-09-17
Decision date: 2005-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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