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FDA 510(k)

SUTURE APPLICATOR

K-Number: K964672 · 1997-02-07

ApplicantLaurus Medical Group
Decision Date1997-02-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUTURE APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Laurus Medical Group. It received FDA 510(k) clearance on 1997-02-07 under 510(k) number K964672. 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 SUTURE APPLICATOR?

SUTURE APPLICATOR is a medical device that received FDA 510(k) clearance on 1997-02-07. The listed applicant is Laurus Medical Group. The 510(k) number is K964672.

When did SUTURE APPLICATOR receive FDA 510(k) clearance?

SUTURE APPLICATOR received FDA 510(k) clearance on 1997-02-07, under 510(k) number K964672.

Who is the listed applicant for SUTURE APPLICATOR?

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

What is the FDA product code for SUTURE APPLICATOR?

The FDA product code for SUTURE APPLICATOR is GCJ.

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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