FDA 510(k)

PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.

K-Number: K022664 · 2002-09-10

ApplicantArc Medical Supplies (Beijing) Co, Ltd.

Decision Date2002-09-10

Product CodeGAM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. 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 2002-09-10 under 510(k) number K022664. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.?

PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. is a medical device that received FDA 510(k) clearance on 2002-09-10. The listed applicant is Arc Medical Supplies (Beijing) Co, Ltd.. The 510(k) number is K022664.

When did PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. receive FDA 510(k) clearance?

PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. received FDA 510(k) clearance on 2002-09-10, under 510(k) number K022664.

Who is the listed applicant for PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.?

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 PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.?

The FDA product code for PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. is GAM.

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

K022666PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.K000542PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP K000541SILK NONABSORBABLE SURGICAL SUTURES, USP K000537POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP K000539NYLON NONABSORBABLE SURGICAL SUTURES, USP K000540POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

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Related Devices (Code: GAM)

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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.