SportSuite Vision Software— 510(k) DEN250040
UnknownStryker Endoscopy
FDA 510(k) clearance DEN250040 for SportSuite Vision Software, Unknown on 2026-07-17. Applicant: Stryker Endoscopy. Device class: 2.
Summary
Stryker Endoscopy's SportSuite Vision Software is filed under SIT, arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display systems. The record doesn't describe what the software displays.
Class II, 21 CFR 888.1150. Orthopedic is both the classification panel and the review panel. The record lists the submission type as Direct.
Stryker Endoscopy filed from San Jose, California. The decision date came 318 calendar days after the received date (September 2, 2025 to July 17, 2026).
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Product code SIT
- Device class
- Class 2
- Regulation
- 21 CFR 888.1150
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- San Jose, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.