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FDA 510(k)

CATGUT SUTURE PLAIN

K-Number: K931918 · 1994-03-03

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

Device Summary

CATGUT SUTURE PLAIN 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 K931918. 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 PLAIN?

CATGUT SUTURE PLAIN 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 K931918.

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

CATGUT SUTURE PLAIN received FDA 510(k) clearance on 1994-03-03, under 510(k) number K931918.

Who is the listed applicant for CATGUT SUTURE PLAIN?

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 PLAIN?

The FDA product code for CATGUT SUTURE PLAIN 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 POLYLMIDEK931916SUTURE NON-ABSORBABLE SYNTHETIC POLYESTERK931913SUTURE NON-ABSORBABLE SILKK931915STAINLESS STEEL SUTUREK931917SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENEK931919CATGUT SUTURE CHROMIC

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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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