ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor— 510(k) K163313

Substantially Equivalent

CIVCO Medical Instruments Co., Inc.

FDA 510(k) clearance K163313 for ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor, Substantially Equivalent on 2017-06-09. Applicant: CIVCO Medical Instruments Co., Inc..

Clearance details

Applicant: CIVCO Medical Instruments Co., Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2016-11-23
Decision date: 2017-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deep River, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.