FDA 510(k)

GYRUS ACMI BICOAG HEMOSTASIS PROBE

K-Number: K123319 · 2012-12-14

ApplicantOlympus Surgical Technologies America

Decision Date2012-12-14

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

GYRUS ACMI BICOAG HEMOSTASIS PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K123319. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ACMI BICOAG HEMOSTASIS PROBE?

GYRUS ACMI BICOAG HEMOSTASIS PROBE is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K123319.

When did GYRUS ACMI BICOAG HEMOSTASIS PROBE receive FDA 510(k) clearance?

GYRUS ACMI BICOAG HEMOSTASIS PROBE received FDA 510(k) clearance on 2012-12-14, under 510(k) number K123319.

Who is the listed applicant for GYRUS ACMI BICOAG HEMOSTASIS PROBE?

The FDA 510(k) record lists Olympus Surgical Technologies America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYRUS ACMI BICOAG HEMOSTASIS PROBE?

The FDA product code for GYRUS ACMI BICOAG HEMOSTASIS PROBE is KNS.

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Related Devices (Code: KNS)

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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.