510(k) K132439— SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER

Substantially Equivalent

Sakura Seiki Co., Ltd.

Clearance details

Applicant: Sakura Seiki Co., Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2013-08-05
Decision date: 2014-01-06
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.