Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008361498

FEI Number

3008361498

Entity Name

Covidien

City/State/Country

Plainfield, IN, US

Establishment Address

2800 Airwest Blvd, Suite 160, Plainfield, IN 46168, US

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Valleylab Blade Electrode Valleylab¿ Ball Electrode Valleylab¿ Straight Extension Valleylab Needle Electrode Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm, E1005 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552NSB Valleylab Ball Electrode, Reusable, 5.6 mm, E1002 Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm), E1551XNSB Valleylab Ball Electrode, 6.5" (16.51 cm), E1551-6NSB Valleylab Straight Extension, 34.3 cm, E1504 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552 Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm), E1003 Valleylab Ball Electrode, Reusable, 3.2 mm, E1000 Valleylab Straight Extension, 13 cm, E1502 Valleylab Ball Electrode, 5 mm, E1550 Valleylab Return Electrode Monitor Valleylab Multiple Return/S Cord Adapter, E0507-B Emprint Microwave Ablation System- CAMSYS Footswitch- RFASW; & Remote Temperature Probe- RTP20 Includes Generator- CAGEN1; Percutaneous Antenna- CA15L1, CA20L1, CA30L1; Pump- CAPUMP1; Reusable Cable- CA190RC1 Current Monitor E3351 Current Monitor E3350 Endoflip 300 System Pediatric-Infant Adhesive Sensor Wrap Adult-Neonatal Adhesive Sensor Wrap Adult-Neonatal Foam Sensor Wrap Pediatric-Infant Foam Sensor Wrap Force Argon II System Valleylab Argon Tank Regulator, GR200A-20 Valleylab Argon Tank Regulator, GR200A Emprint Ablation System with Thermosphere Technology Monopolar Cords ForceTriad Bipolar Resection Activation Kit ForceTriad Bipolar Resection Activation Kit, FTBRKIT Bipolar Forceps Cord ForceTriad Bipolar Resection Cord Stroz, Reusable, 15' (4.6m), FT0021S ForceTriad Monopolar Cord 15' (4.6 m), FT0510 ForceTriad Bipolar Resection Cord Wolf, Reusable, 15' (4.6m), FT0022W Valleylab Bipolar Forceps Cord, 12' (3.6 m), E0512 PillCam capsule ForceTriad Remote Control Activation Kit, FTRCKIT Adapters Valleylab REM Patient Return Electrode Adapter, E0600 Valleylab Monopolar Adapter , E0502-1 Valleylab Universal Monopolar Adapter, E0017 Valleylab Active Adapter, E0005-3C

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-04-11
JOS	Electrode, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2007-12-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2014-05-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2023-07-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-05-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-30
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-14
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2022-06-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-06-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3006451981	Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai, CN
8044004	ORIDION MEDICAL 1987 LTD.	JERUSALEM, IL
1282497	Covidien LLC	MANSFIELD, MA, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19
K142547	Covidien	Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm	2014-12-09
K130320	Covidien	BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW	2014-02-04
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0037-05	N/A	2	NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
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

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008361498. Last updated year: 2026. Please use registration number 3008361498 when referencing this establishment in official correspondence.