FDA.report

510(k) K210651

Device
Resection Electrodes with HF cable
Applicant
Olympus Winter & Ibe GmbH
510(k) number
K210651
Product code
FAS
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-03
Date received
2021-03-04
Regulation
876.4300
Classification name
Electrode, Electrosurgical, Active, Urological
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Katharina Campbell
Address
Kuehnstr, 61 Hamburg DE 22045 22045

FDA Registration Numbers

Source Documents

510(k) summary PDF

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