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FDA 510(k)

PLAIN/CHROMIC CATGUT

K-Number: K994002 · 2000-02-04

ApplicantTrading Consultants and Distributors Intl., Inc.
Decision Date2000-02-04
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLAIN/CHROMIC CATGUT is the device name listed in this FDA 510(k) record. The listed applicant is Trading Consultants and Distributors Intl., Inc.. It received FDA 510(k) clearance on 2000-02-04 under 510(k) number K994002. 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 PLAIN/CHROMIC CATGUT?

PLAIN/CHROMIC CATGUT is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Trading Consultants and Distributors Intl., Inc.. The 510(k) number is K994002.

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

PLAIN/CHROMIC CATGUT received FDA 510(k) clearance on 2000-02-04, under 510(k) number K994002.

Who is the listed applicant for PLAIN/CHROMIC CATGUT?

The FDA 510(k) record lists Trading Consultants and Distributors Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLAIN/CHROMIC CATGUT?

The FDA product code for PLAIN/CHROMIC CATGUT is GAL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Trading Consultants and Distributors Intl., Inc. 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.

K994001POLYGLYCOLIC ACIDK993997POLYPROPYLENEK993998NYLONK993999SILKK994000POLYESTER

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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