FDA 510(k)

GYRUS ACMI BIOCOAG PROBE

K-Number: K092571 · 2010-10-20

Decision Date2010-10-20

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

GYRUS ACMI BIOCOAG PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2010-10-20 under 510(k) number K092571. 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 BIOCOAG PROBE?

GYRUS ACMI BIOCOAG PROBE is a medical device that received FDA 510(k) clearance on 2010-10-20. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K092571.

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

GYRUS ACMI BIOCOAG PROBE received FDA 510(k) clearance on 2010-10-20, under 510(k) number K092571.

Who is the listed applicant for GYRUS ACMI BIOCOAG PROBE?

The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYRUS ACMI BIOCOAG PROBE?

The FDA product code for GYRUS ACMI BIOCOAG PROBE is 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.