FDA AI Clearance Tracker/K253984
Gastroenterology-Urology · 510(k)
Instrument Exit Point on Touch Surgery Aide
Covidien, LLC
- Device
- Instrument Exit Point on Touch Surgery Aide
- Company
- Covidien, LLC
- Submission number
- K253984
- Pathway
- 510(k)
- Decision date
- Jun 4, 2026
- Specialty (lead panel)
- Gastroenterology-Urology
- Primary product code
- SFE
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.