STERICOVER— 510(k) K853044

Substantially Equivalent

Sterimed, Inc.

FDA 510(k) clearance K853044 for STERICOVER, Substantially Equivalent on 1985-11-01. Applicant: Sterimed, Inc..

Clearance details

Applicant: Sterimed, Inc.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1985-07-19
Decision date: 1985-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acworth, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.