510(k) K253984
- Device
- Instrument Exit Point on Touch Surgery™ Aide
- Applicant
- Covidien, LLC
- 510(k) number
- K253984
- Product code
- SFE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-04
- Date received
- 2025-12-12
- Regulation
- 876.1500
- Classification name
- Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Atbin Malayeri
- Address
- 15 Hampshire St. Mansfield MA US 02048 02048
Source Documents#
Other 510(k) Records For Product Code SFE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | 2025-06-24 |