TORRENT IRRIGATION SYSTEM— 510(k) K140405

Name: FDA 510(k) clearance K140405
Creator: U.S. Food and Drug Administration
Published: 2014-03-12

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K140405 for TORRENT IRRIGATION SYSTEM, Substantially Equivalent on 2014-03-12. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2014-02-18
Decision date: 2014-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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