510(k) K220102— MOST-T Autoclave

Substantially Equivalent

Shinva Medical Instrument Co., Ltd.

Clearance details

Applicant: Shinva Medical Instrument Co., Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2022-01-12
Decision date: 2022-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, CN

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.