K122774

Substantially Equivalent

SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG

Applicant: Sakura Seiki Co., Ltd.
Product code: FLE
Advisory panel: General Hospital
Date received: 2012-09-10
Decision date: 2013-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chikuma, Nagano, JP

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.