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FDA 510(k)

POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

K-Number: K000540 · 2000-04-27

ApplicantArc Medical Supplies (Beijing) Co, Ltd.
Decision Date2000-04-27
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 Arc Medical Supplies (Beijing) Co, Ltd.. It received FDA 510(k) clearance on 2000-04-27 under 510(k) number K000540. 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 2000-04-27. The listed applicant is Arc Medical Supplies (Beijing) Co, Ltd.. The 510(k) number is K000540.

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

POLYESTER NONABSORBABLE SURGICAL SUTURES, USP received FDA 510(k) clearance on 2000-04-27, under 510(k) number K000540.

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

The FDA 510(k) record lists Arc Medical Supplies (Beijing) Co, Ltd. 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.

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Other records listing Arc Medical Supplies (Beijing) Co, Ltd. 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.

K022666PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.K022664PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.K000542PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USPK000541SILK NONABSORBABLE SURGICAL SUTURES, USPK000537POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USPK000539NYLON NONABSORBABLE SURGICAL SUTURES, USP

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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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