Clearance Summary
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor received FDA 510(k) clearance under submission number K163313, sponsored by CIVCO Medical Instruments Co., 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 2017-06-09.
- Submission: K163313
- Applicant / Sponsor: CIVCO Medical Instruments Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 2017-06-09
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.