Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004904811

FEI Number

3004904811

Entity Name

Covidien llc

City/State/Country

Santa Clara, CA, US

Establishment Address

3062 Bunker Hill Lane, Santa Clara, CA 95054, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K172128

PMA Number

N/A

All Registered Proprietary Names

Barrx RFA Endoscopic Guidewire HET Temperature Monitor, HET Bipolar Forceps, HET Reusable Cable ProdiGI BNX Fine Needle Aspiration System HALOFLEX Energy Generator Barrx Flex RFA Energy Generator HALO90 System HALO90 Ablation Catheter Barrx 90 RFA Focal Catheter Flip Topography Module EndoFlip Catheter EndoFlip System HALO90 ULTRA Ablation Catheter Barrx Ultra Long RFA Focal Catheter Barrx Flex RFA Energy Generator EsoFLIP ES-330 Beacon Fine Needle Aspiration System Barrx Anorectal RFA Wand Barrx Channel RFA Endoscopic Catheter Endoflip 300 System HALO360+ Ablation Catheter and HALO Cap Barrx 360 RFA Balloon Catheter and Barrx RFA Cleaning Cap Barrx 60 RFA Focal Catheter HALO60 Ablation Catheter Barrx 360 Express RFA Balloon Catheter Barrx RFA Self-Sizing Balloon Catheter Beacon Fine Needle Fiducial System Cytosponge Beacon EUS Access System HET Bipolar System EsoFlip Catheter ES-310

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2014-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-10-24
QSW	Endoscopic Traction Device	Gastroenterology, Urology	Class 2	876.4410	2022-06-20
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2014-11-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-04-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-04-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-04-19
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2019-08-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-05-31
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-05-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-06-26
PIE	Esophageal Dilator With Balloon And Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2014-01-06
PID	Esophageal Dilator Balloon With Or Without Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2014-01-06
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2017-06-26
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-06-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-09-09
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2013-08-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-08-12
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2023-07-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-04-19
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2012-04-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-04-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-11-19
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2016-04-05
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-04-05
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2018-09-18
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2018-09-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-08-16
PIE	Esophageal Dilator With Balloon And Electrode Sensors	Gastroenterology, Urology	Class 2	876.5980	2019-08-20

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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

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-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Similar Registrations

Registration Number	Establishment Name	Location
3025772870	ENTERAL ACCESS TECHNOLOGIES, LTD.	Caerwys Flintshire, GB
3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
1649518	Sterigenics US LLC	Fort Worth, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004904811. Last updated year: 2026. Please use registration number 3004904811 when referencing this establishment in official correspondence.