BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON; PENTAX COMPATIBLE; DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE— 510(k) K142068

Name: FDA 510(k) clearance K142068
Creator: U.S. Food and Drug Administration
Published: 2015-03-10

Substantially Equivalent

Medovations, Inc.

FDA 510(k) clearance K142068 for BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON; PENTAX COMPATIBLE; DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE, Substantially Equivalent on 2015-03-10. Applicant: Medovations, Inc.. Device class: 2.

Clearance details

Device name as filed: BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE
Applicant: Medovations, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2014-07-30
Decision date: 2015-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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