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FDA 510(k)

SURGICAL CUTTER

K-Number: K955168 · 1996-01-22

ApplicantPromex, Inc.
Decision Date1996-01-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Promex, Inc.. It received FDA 510(k) clearance on 1996-01-22 under 510(k) number K955168. 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 SURGICAL CUTTER?

SURGICAL CUTTER is a medical device that received FDA 510(k) clearance on 1996-01-22. The listed applicant is Promex, Inc.. The 510(k) number is K955168.

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

SURGICAL CUTTER received FDA 510(k) clearance on 1996-01-22, under 510(k) number K955168.

Who is the listed applicant for SURGICAL CUTTER?

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

What is the FDA product code for SURGICAL CUTTER?

The FDA product code for SURGICAL CUTTER 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.

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