FDA 510(k)

PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.

K-Number: K022666 · 2002-10-09

ApplicantArc Medical Supplies (Beijing) Co, Ltd.

Decision Date2002-10-09

Product CodeNEW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PDO (POLYDIOXANONE) MONOFILAMENT 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 2002-10-09 under 510(k) number K022666. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.?

PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. is a medical device that received FDA 510(k) clearance on 2002-10-09. The listed applicant is Arc Medical Supplies (Beijing) Co, Ltd.. The 510(k) number is K022666.

When did PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. receive FDA 510(k) clearance?

PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. received FDA 510(k) clearance on 2002-10-09, under 510(k) number K022666.

Who is the listed applicant for PDO (POLYDIOXANONE) MONOFILAMENT 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 PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.?

The FDA product code for PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. is NEW.

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

K022664PGA (POLYGLYCOLIC) 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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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.