510(k) DEN250040

SportSuite Vision Software by Stryker Endoscopy — Product Code SIT

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