510(k) K251041 · FDS Gastroscope And Accessories, Flexible/Rigid
GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
| Applicant | Actuated Medical, Inc., Bellefonte PA, US |
| Decision | Substantially Equivalent, Oct 31, 2025 |
| Received | Apr 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251041
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.