510(k) DEN250040
DEN250040 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "SportSuite Vision Software". The FDA issued a decision of De Novo Granted on July 17, 2026. Stryker Endoscopy has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 17, 2026
- Date Received
- September 2, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No