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FDA 510(k)

NYLON NONABSORBABLE SURGICAL SUTURES, USP

K-Number: K000539 · 2000-04-27

ApplicantArc Medical Supplies (Beijing) Co, Ltd.
Decision Date2000-04-27
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

NYLON 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 K000539. 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 NONABSORBABLE SURGICAL SUTURES, USP?

NYLON 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 K000539.

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

NYLON NONABSORBABLE SURGICAL SUTURES, USP received FDA 510(k) clearance on 2000-04-27, under 510(k) number K000539.

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

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

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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, USPK000540POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

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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

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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