FDA 510(k)

FASCIA STITCHER

K-Number: K934527 · 1994-02-25

Decision Date1994-02-25

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FASCIA STITCHER is the device name listed in this FDA 510(k) record. The listed applicant is Laparomed Corp.. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K934527. 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 FASCIA STITCHER?

FASCIA STITCHER is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Laparomed Corp.. The 510(k) number is K934527.

When did FASCIA STITCHER receive FDA 510(k) clearance?

FASCIA STITCHER received FDA 510(k) clearance on 1994-02-25, under 510(k) number K934527.

Who is the listed applicant for FASCIA STITCHER?

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

What is the FDA product code for FASCIA STITCHER?

The FDA product code for FASCIA STITCHER is GCJ.

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Other records listing Laparomed Corp. as applicant

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Related Devices (Code: GCJ)

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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.