510(k) K120149— SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA

Substantially Equivalent

Sakura Seiki Co., Ltd.

Clearance details

Applicant: Sakura Seiki Co., Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2012-01-18
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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.