FDA 510(k)

BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910

K-Number: K012018 · 2002-07-16

Decision Date2002-07-16

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 is the device name listed in this FDA 510(k) record. The listed applicant is Acmi Corporation. It received FDA 510(k) clearance on 2002-07-16 under 510(k) number K012018. 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 BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910?

BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 is a medical device that received FDA 510(k) clearance on 2002-07-16. The listed applicant is Acmi Corporation. The 510(k) number is K012018.

When did BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 receive FDA 510(k) clearance?

BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 received FDA 510(k) clearance on 2002-07-16, under 510(k) number K012018.

Who is the listed applicant for BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910?

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

What is the FDA product code for BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910?

The FDA product code for BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 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.