Clearance Summary
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover received FDA 510(k) clearance under submission number K200493, sponsored by Stryker Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2020-03-21.
- Submission: K200493
- Applicant / Sponsor: Stryker Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2020-03-21
Classification & Regulation
This clearance is catalogued under FDA product code FXY and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.