AMSCO 600 Steam Sterilizer— 510(k) K232485

Substantially Equivalent

Steris

FDA 510(k) clearance K232485 for AMSCO 600 Steam Sterilizer, Substantially Equivalent on 2023-09-13. Applicant: Steris.

Clearance details

Applicant: Steris
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2023-08-16
Decision date: 2023-09-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

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.