Family of Steam Sterilizers B 28 series— 510(k) K151597

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K151597 for Family of Steam Sterilizers B 28 series, Substantially Equivalent on 2016-03-04. Applicant: Cefla S.C..

Clearance details

Applicant: Cefla S.C.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2015-06-12
Decision date: 2016-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola (Bo), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.