Data / Medical devices / United States / Actuated Medical, Inc.
Actuated Medical, Inc.: FDA-registered device maker in Bellefonte, PA, United States, 6 510(k) clearances
Actuated Medical, Inc. is registered with the FDA (registration 3009698186) in Bellefonte, PA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009698186
- Address
- 320 Rolling Ridge Dr, Bellefonte, PA, United States, 16823
- Owner or operator
- Actuated Medical, Inc. (10041111)
- Roles
- Manufacturer
- First device listed
- December 5, 2013
- Registered through
- 2026
- Brand names listed
- GripTract-GI Endoscopic Tissue Manipulator, TubeClear, TubeClear Clearing Stem Models TC-1018, TC-0812, TC-0608
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Manufacturer | accessdata.fda.gov |
| Gastroscope And Accessories, Flexible/Rigid | FDS | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Feeding | FPD | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 31, 2025 | K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | FDS | Substantially Equivalent | Actuated Medical, Inc. | accessdata.fda.gov |
| October 4, 2024 | K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | FDF | Substantially Equivalent | Actuated Medical, Inc. | accessdata.fda.gov |
| December 4, 2020 | K200646 | TubeClear System | KNT | Substantially Equivalent | Actuated Medical, Inc. | accessdata.fda.gov |
| June 29, 2018 | K172556 | TubeClear System | KNT | Substantially Equivalent | Actuated Medical, Inc. | accessdata.fda.gov |
| November 30, 2016 | K163092 | TubeClear Control Box and Clearing Stem | KNT | Substantially Equivalent | Actuated Medical, Inc. | accessdata.fda.gov |
| August 16, 2013 | K131052 | TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) | KNT | Substantially Equivalent | Actuated Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gastroscope And Accessories, Flexible/Rigid
- All makers of Tube, Feeding
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Colonoscope And Accessories, Flexible/Rigid
Updated October 31, 2025. 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.