EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,— 510(k) K131161

Substantially Equivalent

CIVCO Medical Instruments Co., Inc.

FDA 510(k) clearance K131161 for EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,, Substantially Equivalent on 2013-09-17. Applicant: CIVCO Medical Instruments Co., Inc..

Clearance details

Applicant: CIVCO Medical Instruments Co., Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 2013-04-24
Decision date: 2013-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalona, IA, US

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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.