SportSuite Vision Software
FDA 510(k) clearance DEN250040 · decided 2026-07-17
Clearance details
- K-number
- DEN250040
- Device name
- SportSuite Vision Software
- Applicant
- Stryker Endoscopy
- Decision
- Unknown
- Date received
- 2025-09-02
- Decision date
- 2026-07-17
- Days to decision
- 318 days
- Clearance type
- Direct
- Product code
- SIT
- Device class
- 2
- Regulation number
- 888.1150
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.