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FDA 510(k)

Bipolar applicator CELON ProCurve V

K-Number: K172535 · 2017-11-16

ApplicantOlympus Winter & Ibe GmbH
Decision Date2017-11-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bipolar applicator CELON ProCurve V is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K172535. 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 Bipolar applicator CELON ProCurve V?

Bipolar applicator CELON ProCurve V is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K172535.

When did Bipolar applicator CELON ProCurve V receive FDA 510(k) clearance?

Bipolar applicator CELON ProCurve V received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172535.

Who is the listed applicant for Bipolar applicator CELON ProCurve V?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bipolar applicator CELON ProCurve V?

The FDA product code for Bipolar applicator CELON ProCurve V is GEI.

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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