Clearance Summary
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor received FDA 510(k) clearance under submission number K150504, sponsored by Pci Medical, 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 2015-11-16.
- Submission: K150504
- Applicant / Sponsor: Pci Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2015-11-16
Classification & Regulation
This clearance is catalogued under FDA product code PSW and 21 CFR 892.1570, within the Radiology review panel as a Class II device.