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FDA 510(k)

NYLON NOABSORBABLE SURGICAL SUTURES USP

K-Number: K960327 · 1996-03-04

ApplicantR. K. Medical L. L. C.
Decision Date1996-03-04
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

NYLON NOABSORBABLE 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 1996-03-04 under 510(k) number K960327. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NYLON NOABSORBABLE SURGICAL SUTURES USP?

NYLON NOABSORBABLE SURGICAL SUTURES USP is a medical device that received FDA 510(k) clearance on 1996-03-04. The listed applicant is R. K. Medical L. L. C.. The 510(k) number is K960327.

When did NYLON NOABSORBABLE SURGICAL SUTURES USP receive FDA 510(k) clearance?

NYLON NOABSORBABLE SURGICAL SUTURES USP received FDA 510(k) clearance on 1996-03-04, under 510(k) number K960327.

Who is the listed applicant for NYLON NOABSORBABLE 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 NYLON NOABSORBABLE SURGICAL SUTURES USP?

The FDA product code for NYLON NOABSORBABLE SURGICAL SUTURES USP is GAR.

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 USPK961925POLYESTER NONABSORBABLE SURGICAL SUTURES USPK961389POLYPROPYLENE NONABSORBABLE SURGICAL SUTURESK960328SILK NONABSORBABLE SURGICAL SUTURES USP

Related Devices (Code: GAR)

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.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.

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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