Data / Medical devices / China / Arc Medical Supplies (beijing) Co, Ltd.

Arc Medical Supplies (beijing) Co, Ltd.: FDA-registered device maker in Beijing, China, 7 510(k) clearances

Name: Arc Medical Supplies (beijing) Co, Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Arc Medical Supplies (beijing) Co, Ltd. is registered with the FDA (registration 3003267729) in Beijing, China. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 9, 2002. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003267729
Address: 11 Xingyuan Street Miyun County (inside of Industrial Park), Beijing, China, 101500
Owner or operator: ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. (9052525)
Roles: Manufacturer
First device listed: January 16, 2008
Registered through: 2026
Brand names listed: UNIFY Surgical Sutures, suture

Devices it lists

Device	Product code	Class	Role	Source
Suture, Absorbable, Natural	GAL	2	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 9, 2002	K022666	PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.	NEW	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
September 10, 2002	K022664	PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.	GAM	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 28, 2000	K000542	PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP	GAL	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 28, 2000	K000541	SILK NONABSORBABLE SURGICAL SUTURES, USP	GAP	Substantially Equivalent	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 27, 2000	K000540	POLYESTER NONABSORBABLE SURGICAL SUTURES, USP	GAT	Substantially Equivalent for Some Indications	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 27, 2000	K000539	NYLON NONABSORBABLE SURGICAL SUTURES, USP	GAR	Substantially Equivalent for Some Indications	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov
April 27, 2000	K000537	POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP	GAW	Substantially Equivalent for Some Indications	Arc Medical Supplies (Beijing) Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.