K231254
- 510(k) number
- K231254
- Device name
- GripTract-GI Endoscopic Tissue Manipulator
- Applicant
- Actuated Medical, Inc. PA · US
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2023-11-03
- Date received
- 2023-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K231254.pdf
Official FDA record: K231254
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.