K251041
- 510(k) number
- K251041
- Device name
- GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- Applicant
- Actuated Medical, Inc. PA · US
- Product code
- FDS — Gastroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-10-31
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251041.pdf
Official FDA record: K251041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.