Seal Single-Use Biopsy Valve— 510(k) K161167

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K161167 for Seal Single-Use Biopsy Valve, Substantially Equivalent on 2016-05-26. Applicant: Endochoice, Inc..

Clearance details

Applicant: Endochoice, Inc.
Product code: Code OCX
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-26
Decision date: 2016-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.