FDA 510(k)

CODMAN ISOCOOL BIPOLAR FORCEPS

K-Number: K083895 · 2009-06-23

Decision Date2009-06-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CODMAN ISOCOOL BIPOLAR FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2009-06-23 under 510(k) number K083895. 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 CODMAN ISOCOOL BIPOLAR FORCEPS?

CODMAN ISOCOOL BIPOLAR FORCEPS is a medical device that received FDA 510(k) clearance on 2009-06-23. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K083895.

When did CODMAN ISOCOOL BIPOLAR FORCEPS receive FDA 510(k) clearance?

CODMAN ISOCOOL BIPOLAR FORCEPS received FDA 510(k) clearance on 2009-06-23, under 510(k) number K083895.

Who is the listed applicant for CODMAN ISOCOOL BIPOLAR FORCEPS?

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

What is the FDA product code for CODMAN ISOCOOL BIPOLAR FORCEPS?

The FDA product code for CODMAN ISOCOOL BIPOLAR FORCEPS is GEI.

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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.