K242325
- 510(k) number
- K242325
- Device name
- GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
- Applicant
- Actuated Medical, Inc. PA · US
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-10-04
- Date received
- 2024-08-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242325.pdf
Official FDA record: K242325
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.