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FDA 510(k)

CATGUT SUTURE CHROMIC

K-Number: K931919 · 1994-03-03

ApplicantSurgimetrics International, Ltd.
Decision Date1994-03-03
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CATGUT SUTURE CHROMIC is the device name listed in this FDA 510(k) record. The listed applicant is Surgimetrics International, Ltd.. It received FDA 510(k) clearance on 1994-03-03 under 510(k) number K931919. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATGUT SUTURE CHROMIC?

CATGUT SUTURE CHROMIC is a medical device that received FDA 510(k) clearance on 1994-03-03. The listed applicant is Surgimetrics International, Ltd.. The 510(k) number is K931919.

When did CATGUT SUTURE CHROMIC receive FDA 510(k) clearance?

CATGUT SUTURE CHROMIC received FDA 510(k) clearance on 1994-03-03, under 510(k) number K931919.

Who is the listed applicant for CATGUT SUTURE CHROMIC?

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

What is the FDA product code for CATGUT SUTURE CHROMIC?

The FDA product code for CATGUT SUTURE CHROMIC is GAL.

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Other records listing Surgimetrics International, Ltd. as applicant

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.

K931914SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDEK931918CATGUT SUTURE PLAINK931916SUTURE NON-ABSORBABLE SYNTHETIC POLYESTERK931913SUTURE NON-ABSORBABLE SILKK931915STAINLESS STEEL SUTUREK931917SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE

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Related Devices (Code: GAL)

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.

K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTDemetech Corp.K042287UNIPLAIN & UNICHROMUnited Medical Industries Co. , Ltd.K042897AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGEEthicon Endo-Surgery, Inc.K030227SUTURTEK FASTCLOSE SUTURING DEVICESuturtek IncorporatedK020597SERRALGUTSerral, S.A. DE C.V.K021043GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMICGramsmed, LLC

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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