GSS610N21 Series Steam Sterilizer— 510(k) K214120

Substantially Equivalent

Maquet GmbH

FDA 510(k) clearance K214120 for GSS610N21 Series Steam Sterilizer, Substantially Equivalent on 2022-05-18. Applicant: Maquet GmbH.

Clearance details

Applicant: Maquet GmbH
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2021-12-30
Decision date: 2022-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rastatt, DE

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.