FDA Registration
Active
🇺🇸 United States
ACTUATED MEDICAL, INC.
Reg #: 3009698186
·
FEI: 3009698186
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ACTUATED MEDICAL, INC.
- Registration Number
- 3009698186
- FEI Number
- 3009698186
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 320 Rolling Ridge Dr
- City
- Bellefonte
- State
- PA
- ZIP
- 16823
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242325
Owner / Operator
- Firm Name
- Actuated Medical, Inc.
- Operator Number
- 10041111
- Address
- 320 Rolling Ridge Drive
- City
- Bellefonte
- State
- PA
- Postal Code
- 16823
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2024-12-17 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2020-12-14 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2025-12-17 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2013-12-05 |
Proprietary Names
GripTract-GI Endoscopic Tissue Manipulator
TubeClear
TubeClear Clearing Stem Models TC-1018, TC-0812, TC-0608
Establishment Types
Manufacture Medical Device