FDA 510(k)

CHROMIC CATGUT

K-Number: K943218 · 1994-12-05

Decision Date1994-12-05

Product CodeGAL

Advisory CommitteeSU

DecisionSubstantially Equivalent for Some Indications

Device Summary

CHROMIC CATGUT is the device name listed in this FDA 510(k) record. The listed applicant is Sutures , Ltd.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K943218. The device is classified under product code GAL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CHROMIC CATGUT?

CHROMIC CATGUT is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Sutures , Ltd.. The 510(k) number is K943218.

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

CHROMIC CATGUT received FDA 510(k) clearance on 1994-12-05, under 510(k) number K943218.

Who is the listed applicant for CHROMIC CATGUT?

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

What is the FDA product code for CHROMIC CATGUT?

The FDA product code for CHROMIC CATGUT is GAL.

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Other records listing Sutures , Ltd. as applicant

K990432SURGISORB K953609PRODEK K943223SURGIDEK B K943217PLAIN CATGUT K943222SURGIDEK S K943627SURGISILK

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Related Devices (Code: GAL)

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 Incorporated K020597SERRALGUTSerral, 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.