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FDA 510(k)

FASCIAL CLOSURE DEVICE

K-Number: K931522 · 1994-02-03

ApplicantOrigin Medsystems, Inc.
Decision Date1994-02-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FASCIAL CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K931522. 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 FASCIAL CLOSURE DEVICE?

FASCIAL CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K931522.

When did FASCIAL CLOSURE DEVICE receive FDA 510(k) clearance?

FASCIAL CLOSURE DEVICE received FDA 510(k) clearance on 1994-02-03, under 510(k) number K931522.

Who is the listed applicant for FASCIAL CLOSURE DEVICE?

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

What is the FDA product code for FASCIAL CLOSURE DEVICE?

The FDA product code for FASCIAL CLOSURE DEVICE is GCJ.

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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.

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