AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers— 510(k) K212424
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K212424 for AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers, Substantially Equivalent on 2021-10-28. Applicant: STERIS Corporation. Device class: 2.
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Code FLE
- Device class
- Class 2
- Regulation
- 21 CFR 880.6880
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
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Adverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . 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.