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FDA 510(k)

BICUT

K-Number: K915608 · 1992-07-23

ApplicantBerchtold Holding GmbH
Decision Date1992-07-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BICUT is the device name listed in this FDA 510(k) record. The listed applicant is Berchtold Holding GmbH. It received FDA 510(k) clearance on 1992-07-23 under 510(k) number K915608. 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 BICUT?

BICUT is a medical device that received FDA 510(k) clearance on 1992-07-23. The listed applicant is Berchtold Holding GmbH. The 510(k) number is K915608.

When did BICUT receive FDA 510(k) clearance?

BICUT received FDA 510(k) clearance on 1992-07-23, under 510(k) number K915608.

Who is the listed applicant for BICUT?

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

What is the FDA product code for BICUT?

The FDA product code for BICUT is GEI.

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K083066CHROMOPHARE E 778 AND E 558K080857CHROMOPHARE E-SERIESK024132CHROMOPHARE X 65K990656CHROMOPHARE D 530 LDR SURGICAL LIGHTK991527CHROMOPHARE D500, D530, D650K974433CHROMOPHARE D 500, CHROMOPHARE D 530

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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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