Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006451981

FEI Number

3006451981

Entity Name

Covidien Medical Products (Shanghai) Manufacturing LLC

City/State/Country

Shanghai, CN

Establishment Address

Building #10, 1st Floor of Building #6, 2nd Floor of Building #15, 789 Puxing Road, 201114, Peoples Republic of China, Shanghai 201114, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Covidien llc (Owner Number: 1282497)

Owner / Operator Contact Address

15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152286

PMA Number

N/A

All Registered Proprietary Names

LigaSure Curved, Small Jaw, Open Sealer/Divider Force EZ 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 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator, VLLS10GEN LigaSure Curved Jaw Open Reusable Clamp LigaSure Curved Jaw Open Sealer/Divider Electrode Force FX Force FX Electrosurgical Generator 8CS, Force FX-8CS Force FX Electrosurgical Generator 8CAS Autobipolar, Force FX-8CAS Force FX Electrosurgical Generator 8C, Force FX-8C LigaSure Dolphin Tip Laparoscopic Sealer/Divider, LS1500 LigaSure Tissue Fusion Electrode Straight Jaw, LS2071 Ligasure Tissue Fusion Electrode Curved Jaw, LS3112 LigaSure Atlas Tissue Fusion Laparoscopic Instrument, LS1037 LigaSure Tissue Fusion Electrode Angled Jaw, LS2111 LigaSure Vessel Sealing System, LigaSure 8 LigaSure Atlas Tissue Fusion Open Instrument, LS1020 LigaSure Dolphin Tip Laparoscopic Sealer/Divider LigaSure Dolphin Tip Open Sealer/Divider, LS1520 Ligasure Tissue Fusion Electrode Curved Jaw, LS3092 React 68 Catheter Auto Suture 1960100, HydroCleanse Sinus Wash Delivery System React 71 Catheter Navien Intracranial Support Catheter Lectrovac, Valleylab Models Valleylab Suction Coagulator, E2608-6 LigaSure Curved, Small jaw Open Sealer/Divider, LF1212A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-01-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-26
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2017-01-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-05-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-09-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1992-06-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-03-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	1997-12-04
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2018-09-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-03-10
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2025-03-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-03-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

Dawn Tindall Business: COVIDIEN Email: dawn.d.tindall@medtronic.com Phone: (303) 5817034

Related Public Records

Same Entity

Covidien llc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8020889	Mallinckrodt Medical	ATHLONE Westmeath, IE
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX
2024500	COVIDIEN	CARLSBAD, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006451981. Last updated year: 2026. Please use registration number 3006451981 when referencing this establishment in official correspondence.