GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,— 510(k) K991236

Substantially Equivalent

CIVCO Medical Instruments Co., Inc.

FDA 510(k) clearance K991236 for GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,, Substantially Equivalent on 1999-06-02. Applicant: CIVCO Medical Instruments Co., Inc..

Clearance details

Applicant: CIVCO Medical Instruments Co., Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1999-04-12
Decision date: 1999-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalona, IA, 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.