Clearance Summary
SHEATHES ULTRASOND GEL received FDA 510(k) clearance under submission number K112827, sponsored by Sheathing Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-06-22.
- Submission: K112827
- Applicant / Sponsor: Sheathing Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2012-06-22
Classification & Regulation
This clearance is catalogued under FDA product code MUI and 21 CFR 892.1570, within the Radiology review panel as a Class II device.