GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
FDA 510(k) clearance K251041 · decided 2025-10-31
Clearance details
- K-number
- K251041
- Device name
- GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- Applicant
- Actuated Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-03
- Decision date
- 2025-10-31
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- FDS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bellefonte, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.