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FDA 510(k)

Bipolar Micro-Coagulation Forceps

K-Number: K172368 · 2018-04-05

ApplicantGunter Bissinger Medizintechnik GmbH
Decision Date2018-04-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bipolar Micro-Coagulation Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Gunter Bissinger Medizintechnik GmbH. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K172368. 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 Micro-Coagulation Forceps?

Bipolar Micro-Coagulation Forceps is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Gunter Bissinger Medizintechnik GmbH. The 510(k) number is K172368.

When did Bipolar Micro-Coagulation Forceps receive FDA 510(k) clearance?

Bipolar Micro-Coagulation Forceps received FDA 510(k) clearance on 2018-04-05, under 510(k) number K172368.

Who is the listed applicant for Bipolar Micro-Coagulation Forceps?

The FDA 510(k) record lists Gunter Bissinger Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bipolar Micro-Coagulation Forceps?

The FDA product code for Bipolar Micro-Coagulation Forceps is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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