Clearance Summary
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) received FDA 510(k) clearance under submission number K141551, sponsored by Stryker Corporate. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-09-08.
- Submission: K141551
- Applicant / Sponsor: Stryker Corporate
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2014-09-08
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.