510(k) K020590— MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER

Substantially Equivalent

Getinge/Castle, Inc.

Clearance details

Applicant: Getinge/Castle, Inc.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2002-02-22
Decision date: 2002-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, 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.