510(k) K250268
- Device
- HyperSnap Surgical System (HSS)
- Applicant
- Hypervision Surgical
- 510(k) number
- K250268
- Product code
- SFE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-24
- Date received
- 2025-01-30
- 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
- Jaco Jacobs
- Address
- London Institute For Healthcare Engineering 100 Lambeth Palace Rd. London GB SE1 7AR SE1 7AR
FDA Registration Numbers#
- 3017296423
Source Documents#
Other 510(k) Records For Product Code SFE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253984 | Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | 2026-06-04 |