HyperSnap Surgical System (HSS)
FDA 510(k) clearance K250268 · decided 2025-06-24
Clearance details
- K-number
- K250268
- Device name
- HyperSnap Surgical System (HSS)
- Applicant
- Hypervision Surgical
- Decision
- Substantially Equivalent
- Date received
- 2025-01-30
- Decision date
- 2025-06-24
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- SFE
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- London, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Instrument Exit Point on Touch Surgery™ Aide (K253984) | Covidien, LLC | 2026-06-04 |
Recalls involving this device
No recalls on record reference this clearance.