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FDA 510(k)

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

K-Number: K213610 · 2022-10-07

ApplicantKatalyst Surgical, LLC
Decision Date2022-10-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Katalyst Surgical, LLC. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K213610. 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 Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps?

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Katalyst Surgical, LLC. The 510(k) number is K213610.

When did Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps receive FDA 510(k) clearance?

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps received FDA 510(k) clearance on 2022-10-07, under 510(k) number K213610.

Who is the listed applicant for Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps?

The FDA 510(k) record lists Katalyst Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps?

The FDA product code for Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps is GEI.

Other records listing Katalyst Surgical, LLC as applicant

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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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