Clearance Summary
UNDISTAT WITH EXPLORATOR 35 (UCS 35E) received FDA 510(k) clearance under submission number K883153, sponsored by Bay X-Ray, 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 1988-09-06.
- Submission: K883153
- Applicant / Sponsor: Bay X-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1988-09-06
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.