Clearance Summary
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE received FDA 510(k) clearance under submission number K101889, sponsored by Pivotal Health Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2010-08-27.
- Submission: K101889
- Applicant / Sponsor: Pivotal Health Solutions
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 2010-08-27
Classification & Regulation
This clearance is catalogued under FDA product code ITH and 21 CFR 890.5900, within the Physical Medicine review panel as a Class II device.