Infinity ERCP Sampling Device— 510(k) K151889

Name: FDA 510(k) clearance K151889
Creator: U.S. Food and Drug Administration
Published: 2015-07-30

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K151889 for Infinity ERCP Sampling Device, Substantially Equivalent on 2015-07-30. Applicant: United States Endoscopy Group, Inc.. Device class: 2.

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FDX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-07-10
Decision date: 2015-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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