FDA Registration
Active
🇺🇸 United States
ENDO-THERAPEUTICS, INC.
Reg #: 1056129
·
FEI: 1000132436
·
Expires 2026
Products
13
Proprietary Names
11
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- ENDO-THERAPEUTICS, INC.
- Registration Number
- 1056129
- FEI Number
- 1000132436
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 15251 Roosevelt Blvd Ste 204
- City
- CLEARWATER
- State
- FL
- ZIP
- 33760
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012977
Owner / Operator
- Firm Name
- ENDO-THERAPEUTICS, INC.
- Operator Number
- 9006380
- Address
- 15251 ROOSEVELT BLVD., SUITE 204
- City
- Clearwater
- State
- FL
- Postal Code
- 33760
- Country
- US
- Correspondent
- Susan - Clairmont
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2007-02-15 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2007-04-04 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2007-04-04 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2023-01-02 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2007-11-26 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2023-01-02 |
| Brush, Biopsy, General & Plastic Surgery | GEE | Class 1 | General, Plastic Surgery | No | 2012-10-16 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2007-10-16 |
| Forceps, Biopsy, Bronchoscope (Non-Rigid) | BWH | Class 2 | Ear, Nose, Throat | No | 2007-10-16 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2007-10-16 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2016-06-28 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2025-12-29 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2012-10-16 |
Proprietary Names
EndoTNeedle
EndoTGrasper
EndoTBrush
EndoTExtractor
Bioceps
EndoTBasket
Biopsy Brush
EZ-Snare
Catchem' Polyp Trap
eSuction
SwirlNet
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)