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FDA 510(k)

PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP

K-Number: K961931 · 1996-07-29

ApplicantR. K. Medical L. L. C.
Decision Date1996-07-29
Product CodeGAL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP is the device name listed in this FDA 510(k) record. The listed applicant is R. K. Medical L. L. C.. It received FDA 510(k) clearance on 1996-07-29 under 510(k) number K961931. 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 GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP?

PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP is a medical device that received FDA 510(k) clearance on 1996-07-29. The listed applicant is R. K. Medical L. L. C.. The 510(k) number is K961931.

When did PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP receive FDA 510(k) clearance?

PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP received FDA 510(k) clearance on 1996-07-29, under 510(k) number K961931.

Who is the listed applicant for PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP?

The FDA 510(k) record lists R. K. Medical L. L. C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP?

The FDA product code for PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP 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 R. K. Medical L. L. C. 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.

K961925POLYESTER NONABSORBABLE SURGICAL SUTURES USPK961389POLYPROPYLENE NONABSORBABLE SURGICAL SUTURESK960327NYLON NOABSORBABLE SURGICAL SUTURES USPK960328SILK NONABSORBABLE SURGICAL SUTURES USP

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

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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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