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Foosin Medical Supplies Inc.ltd: FDA-registered device maker in WEIHAI Shandong, China, 10 510(k) clearances

Name: Foosin Medical Supplies Inc.ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Foosin Medical Supplies Inc.ltd is registered with the FDA (registration 3006562124) in WEIHAI Shandong, China. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 20, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006562124
Address: No.8-1, Weigao West Road,Chucun Town, Weihai Torch Hi-tech Science Park, WEIHAI Shandong, China, 264200
Owner or operator: Weigao Group Company Limited (10025293)
Roles: Manufacturer
First device listed: June 11, 2008
Registered through: 2026
Brand names listed: PGA Rapid, PGLA Rapid, WEGO-PDO Barbed Suture, WEGO-PGCL Absorbable Surgical Monofilament Suture, WEGO-PGLA Absorbable Surgical Suture, WEGO-PTFE Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture, Wego Nylon Monofilament Suture, Wego PDO (Monofilament Polydioxanone ) Suture and more

Devices it lists

Device	Product code	Class	Role	Source
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	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
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	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 20, 2020	K201139	WEGO-PDO Barbed Suture	NEW	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
February 19, 2020	K193209	Wego-Stainless Steel	GAQ	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
January 28, 2019	K183004	WEGO-PGA RAPID	GAM	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
January 28, 2019	K183001	WEGO-PGLA RAPID	GAM	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
July 31, 2017	K170842	WEGO-PTFE	NBY	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
November 14, 2014	K142810	WEGO-PGCL Absorbable Surgical Monofilament Suture	GAM	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
January 14, 2014	K130737	SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
January 14, 2014	K130735	SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	Foosin Medical Supplies Inc., Ltd.	accessdata.fda.gov
June 9, 2008	K080684	WG-SURGICAL SUTURES WITH NEEDLE	GAP	Substantially Equivalent	Foosin Medical Supplies, Inc.	accessdata.fda.gov
April 30, 2008	K073614	WG-SURGICAL SUTURES WITH NEEDLE	NEW	Substantially Equivalent	Foosin Medical Supplies, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 20, 2020. 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.