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FDA 510(k)

SILK NONABSORBABLE SURGICAL SUTURES, USP

K-Number: K000541 · 2000-04-28

ApplicantArc Medical Supplies (Beijing) Co, Ltd.
Decision Date2000-04-28
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILK 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 2000-04-28 under 510(k) number K000541. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILK NONABSORBABLE SURGICAL SUTURES, USP?

SILK NONABSORBABLE SURGICAL SUTURES, USP is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Arc Medical Supplies (Beijing) Co, Ltd.. The 510(k) number is K000541.

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

SILK NONABSORBABLE SURGICAL SUTURES, USP received FDA 510(k) clearance on 2000-04-28, under 510(k) number K000541.

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

The FDA product code for SILK NONABSORBABLE SURGICAL SUTURES, USP is GAP.

Related Clinical Trials

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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, USPK000537POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USPK000539NYLON NONABSORBABLE SURGICAL SUTURES, USPK000540POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

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Related Devices (Code: GAP)

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.

K241486Sofsilk™ Coated Braided Silk SutureCovidienK222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.

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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