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Covidien Medical Products (Shanghai) Manufacturing LLC: FDA-registered device maker in Shanghai, China, 14 510(k) clearances

Name: Covidien Medical Products (Shanghai) Manufacturing LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Covidien Medical Products (Shanghai) Manufacturing LLC is registered with the FDA (registration 3006451981) in Shanghai, China. It lists 8 device types. The FDA files 14 510(k) clearances under its listings, the newest dated December 6, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006451981
Address: Building #10, 1st Floor of Building #6, 2nd Floor of Building #15, 789 Puxing Road, 201114 Peoples Republic of China, Shanghai, China, 201114
Owner or operator: Covidien llc (1282497)
Roles: Contract manufacturer, Manufacturer
First device listed: June 29, 1992
Registered through: 2026
Brand names listed: 1960100, HydroCleanse Sinus Wash Delivery System, ATLAS, Auto Suture, Emprint Microwave Ablation System- CAMSYS, Emprint" Reinforced Long Percutaneous Antenna with Thermosphere" Technology, CA30L2, Emprint" Reinforced Short Percutaneous Antenna with Thermosphere" Technology, CA15L2, Emprint" Reinforced Standard Percutaneous Antenna with Thermosphere" Technology, CA20L2, Footswitch- RFASW; & Remote Temperature Probe- RTP20 and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Contract manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Irrigator, Sinus	KAR	1	Contract manufacturer	accessdata.fda.gov
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	POL	2	Contract manufacturer	accessdata.fda.gov
Staple, Implantable	GDW	2	Manufacturer	accessdata.fda.gov
System, Ablation, Microwave And Accessories	NEY	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
December 6, 2016	K163105	Emprint Ablation System	NEY	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
August 12, 2016	K160331	LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp	GEI	Substantially Equivalent	Covidien	accessdata.fda.gov
September 8, 2015	K152286	LigaSure Curved, Small Jaw, Open Sealer/Divider	GEI	Substantially Equivalent	Covidien	accessdata.fda.gov
April 3, 2015	K143654	Valleylab LS10 Generator	GEI	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
April 28, 2014	K133821	EMPRINT ABLATION SYSTEM	NEY	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
September 5, 2012	K113572	LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER	GEI	Substantially Equivalent	Covidien, Formerly Valleylab, A Division of Tyco H	accessdata.fda.gov
September 11, 2009	K091223	VALLEYLAB SUCTION COAGULATOR, MODEL E3305	GEI	Substantially Equivalent	Covidien LP	accessdata.fda.gov
January 5, 2005	K043273	LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS	GEI	Substantially Equivalent	Valleylab	accessdata.fda.gov
May 29, 2003	K031011	LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov
March 26, 2001	K010013	LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov
December 8, 2000	K001895	AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER	GDW	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc	accessdata.fda.gov
August 21, 1995	K953195	VALLEYLAB FORCE 300	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov
June 5, 1995	K944602	VALLEYLAB FORCE FX	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov
October 4, 1979	K791752	LECTROVAC, VALLEYLAB MODELS	GEI	Substantially Equivalent	Valleylab, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 23, 2016	73438	Class II	Terminated	Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of unit	Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint" Percutaneous Antenna.	accessdata.fda.gov

Compare with other makers

Updated December 6, 2016. 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.