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. The device falls under product code SIT (Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System), a Class II device regulated under 21 CFR 888.1150. 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
Device Classification
- Device Name
- Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
- Device Class
- Class II
- Regulation Number
- 888.1150
- Review Panel
- OR
- Submission Type
This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices.