Clearance Summary
TGS Guidewire and updated Scopis Software received FDA 510(k) clearance under submission number K193118, sponsored by Stryker Ent. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-02-21.
- Submission: K193118
- Applicant / Sponsor: Stryker Ent
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2020-02-21
Classification & Regulation
This clearance is catalogued under FDA product code PGW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.