Atlas FDA

Resection Electrodes with HF cable

FDA 510(k) clearance K171965 · decided 2017-09-28

Clearance details

K-number
K171965
Device name
Resection Electrodes with HF cable
Applicant
Olympus Winter & Ibe GmbH
Decision
Substantially Equivalent
Date received
2017-06-30
Decision date
2017-09-28
Days to decision
90 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hamburg, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S recall (Z-0424-2023)Olympus Corporation of the Americas2022-12-07