Monopolar single-use HF cable
K-Number: K160053 · 2016-05-06
ApplicantOlympus Winter & Ibe GmbH
Decision Date2016-05-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Monopolar single-use HF cable is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2016-05-06 under approval number K160053. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Monopolar single-use HF cable?
Monopolar single-use HF cable is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K160053.
When was Monopolar single-use HF cable approved by the FDA?
Monopolar single-use HF cable received FDA 510(k) clearance on 2016-05-06, under approval number K160053.
What company makes Monopolar single-use HF cable?
Monopolar single-use HF cable is manufactured by Olympus Winter & Ibe GmbH.
What is the FDA product code for Monopolar single-use HF cable?
The FDA product code for Monopolar single-use HF cable is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.