ScopeSeal Duodenoscope Protective Device— 510(k) K183171

Name: FDA 510(k) clearance K183171
Creator: U.S. Food and Drug Administration
Published: 2019-10-08

Substantially Equivalent

Gi Scientific, LLC

FDA 510(k) clearance K183171 for ScopeSeal Duodenoscope Protective Device, Substantially Equivalent on 2019-10-08. Applicant: Gi Scientific, LLC. Device class: 2.

Clearance details

Applicant: Gi Scientific, LLC
Product code: Code ODB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-11-16
Decision date: 2019-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

Download summary PDF View on FDA.gov ↗

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