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FDA 510(k)

CUTTER, SURGICAL

K-Number: K925382 · 1993-09-03

ApplicantMectra Laboratories, Inc.
Decision Date1993-09-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CUTTER, SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Mectra Laboratories, Inc.. It received FDA 510(k) clearance on 1993-09-03 under 510(k) number K925382. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTTER, SURGICAL?

CUTTER, SURGICAL is a medical device that received FDA 510(k) clearance on 1993-09-03. The listed applicant is Mectra Laboratories, Inc.. The 510(k) number is K925382.

When did CUTTER, SURGICAL receive FDA 510(k) clearance?

CUTTER, SURGICAL received FDA 510(k) clearance on 1993-09-03, under 510(k) number K925382.

Who is the listed applicant for CUTTER, SURGICAL?

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

What is the FDA product code for CUTTER, SURGICAL?

The FDA product code for CUTTER, SURGICAL is GCJ.

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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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