FDA Registration
Active
🇺🇸 United States
Covidien llc
Reg #: 3004962788
·
FEI: 3004962788
·
Expires 2026
Products
11
Proprietary Names
17
Establishment Types
6
Classifications
11
Registration Details
- Registration Name
- Covidien llc
- Registration Number
- 3004962788
- FEI Number
- 3004962788
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 161 CHESHIRE LANE, SUITE 100
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163537
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2017-04-21 |
| Brush, Biopsy, Bronchoscope (Non-Rigid) | BTG | Class 2 | Ear, Nose, Throat | No | 2014-01-28 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-01-25 |
| Forceps, Biopsy, Bronchoscope (Non-Rigid) | BWH | Class 2 | Ear, Nose, Throat | No | 2013-01-25 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2013-01-25 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2017-09-20 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2013-01-25 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2013-01-25 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2013-01-25 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2013-01-25 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
Proprietary Names
Arcpoint
Emprint
SuperLock
Emprint Microwave Ablation System- CAMSYS
Footswitch- RFASW; & Remote Temperature Probe- RTP20
Includes Generator- CAGEN1; Percutaneous Antenna- CA15L1, CA20L1, CA30L1; Pump- CAPUMP1; Reusable Cable- CA190RC1
InReach System
GenCut Core Biopsy System
ILLUMISITE Endobronchial Procedure Kit 180 Catheter
ILLUMISITE Bronchoscope Adapter Olympus
ILLUMISITE Endobronchial Procedure Kit 90 Catheter
ILLUMISITE Bronchoscope Adapter Pentax
ILLUMISITE Bronchoscope Adapter Olympus 190
ILLUMISITE Console
ILLUMISITE Patient Sensor Patch
ILLUMISITE Bronchoscope Adapter Fujinon
ILLUMISITE Endobronchial Procedure Kit 45 Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198