CleverLock Guidewire Locking Device and Biopsy Cap— 510(k) K190164

Substantially Equivalent

Olympus Surgical Technologies America

FDA 510(k) clearance K190164 for CleverLock Guidewire Locking Device and Biopsy Cap, Substantially Equivalent on 2019-04-04. Applicant: Olympus Surgical Technologies America. Device class: 2.

Clearance details

Applicant
Olympus Surgical Technologies America
Product code
Code ODC
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Southborough, MA, US
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