Data / Medical devices / United States / Covidien llc

Covidien llc: FDA-registered device maker in Plymouth, MN, United States, 16 510(k) clearances

Name: Covidien llc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Covidien llc is registered with the FDA (registration 3004962788) in Plymouth, MN, United States. It lists 11 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 7, 2019. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004962788
Address: 161 Cheshire Lane Suite 100, Plymouth, MN, United States, 55441
Owner or operator: Covidien llc (1282497)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: January 25, 2013
Registered through: 2026
Brand names listed: Arcpoint, Emprint, Emprint Microwave Ablation System- CAMSYS, Footswitch- RFASW; & Remote Temperature Probe- RTP20, GenCut Core Biopsy System, ILLUMISITE Bronchoscope Adapter Fujinon, ILLUMISITE Bronchoscope Adapter Olympus, ILLUMISITE Bronchoscope Adapter Olympus 190 and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Repackager or relabeler	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Brush, Biopsy, Bronchoscope (Non-Rigid)	BTG	2	Specification developer	accessdata.fda.gov
Endoscopic Cytology Brush	FDX	2	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Bronchoscope (Non-Rigid)	BWH	2	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Repackager or relabeler	accessdata.fda.gov
System, Ablation, Microwave And Accessories	NEY	2	Contract manufacturer, Manufacturer for export	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Complaint file establishment, Manufacturer, Specification developer	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
August 7, 2019	K191394	ILLUMISITE Platform	JAK	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
February 8, 2018	K173244	superDimension Navigation System V7.2	JAK	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
April 21, 2017	K163537	Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga	EOQ	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
November 5, 2015	K151376	superDimension Navigation System	JAK	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
June 17, 2015	K142934	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	EOQ	Substantially Equivalent	Covidien	accessdata.fda.gov
April 29, 2015	K142839	GenCut Core Biopsy System	EOQ	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
November 6, 2013	K130357	SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH	BTG	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
October 26, 2012	K120796	SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER	JAK	Substantially Equivalent	Superdimension, Inc.	accessdata.fda.gov
February 11, 2011	K110093	SUPERDIMENSION MARKER DELIVERY KIT	JAK	Substantially Equivalent	Superdimension, Inc.	accessdata.fda.gov
October 7, 2010	K102604	I-LOGIC INREACH SYSTEM	JAK	Substantially Equivalent	Superdimension, Ltd.	accessdata.fda.gov
February 24, 2010	K100267	FLEXIMARC, MODEL CM-0.9-2-10-GG-L	IYE	Substantially Equivalent	Cortex Manufacturing, Inc.	accessdata.fda.gov
September 4, 2009	K092365	INREACH SYSTEM, MODEL AAS00161-02	JAK	Substantially Equivalent	Superdimension, Ltd.	accessdata.fda.gov
September 16, 2008	K082386	INREACH PLANNING LAPTOP	LLZ	Substantially Equivalent	Superdimension, Ltd.	accessdata.fda.gov
November 5, 1993	K925392	BIOPSY FORCEPS	FCL	Substantially Equivalent	Endo-Therapeutics, Inc.	accessdata.fda.gov
March 4, 1986	K860582	TBI NEEDLE	GAA	Substantially Equivalent	Hobbs Medical, Inc.	accessdata.fda.gov
February 4, 1984	K834402	GASTROINTESTINAL SHEATH BRUSH	FDX	Substantially Equivalent	Hobbs Medical, 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
May 22, 2023	92394	Class II	Ongoing	Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS	Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.	accessdata.fda.gov
November 23, 2022	91318	Class II	Ongoing	COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1	The product is labeled with the incorrect expiration date.	accessdata.fda.gov
June 18, 2012	62381	Class II	Terminated	superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract	superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx. The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 wi	accessdata.fda.gov
November 29, 2006	36947	Not yet classified	Terminated	superDimension Bronchus System (AAS00016-01), an image-guided localization system used to guide endoscopic tools to predetermined targets within the pulmonary tract.	The action is being taken in response to certain incidents that have been reported to the company, one of which concerned an adverse event in which a patient incurred a pneumothorax during a procedure in which a superDimension Bronchus System was used. The biopsy results for the patient were taken from a different area than the confirmed navigation site that	accessdata.fda.gov

Compare with other makers

Updated June 26, 2023. 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.