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FDA 510(k)

POLYESTER NONABSORBABLE SURGICAL SUTURES USP

K-Number: K961925 · 1996-07-29

ApplicantR. K. Medical L. L. C.
Decision Date1996-07-29
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

POLYESTER NONABSORBABLE 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 K961925. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the POLYESTER NONABSORBABLE SURGICAL SUTURES USP?

POLYESTER NONABSORBABLE 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 K961925.

When did POLYESTER NONABSORBABLE SURGICAL SUTURES USP receive FDA 510(k) clearance?

POLYESTER NONABSORBABLE SURGICAL SUTURES USP received FDA 510(k) clearance on 1996-07-29, under 510(k) number K961925.

Who is the listed applicant for POLYESTER NONABSORBABLE 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 POLYESTER NONABSORBABLE SURGICAL SUTURES USP?

The FDA product code for POLYESTER NONABSORBABLE SURGICAL SUTURES USP is GAT.

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.

K961931PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USPK961389POLYPROPYLENE NONABSORBABLE SURGICAL SUTURESK960327NYLON NOABSORBABLE SURGICAL SUTURES USPK960328SILK NONABSORBABLE SURGICAL SUTURES USP

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

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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