Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile— 510(k) K191715

Name: FDA 510(k) clearance K191715
Creator: U.S. Food and Drug Administration
Published: 2020-01-27

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K191715 for Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile, Substantially Equivalent on 2020-01-27. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code OCU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-06-26
Decision date: 2020-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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