AMSCO 700 Steam Sterilizer— 510(k) K261055
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K261055 for AMSCO 700 Steam Sterilizer, Substantially Equivalent on 2026-06-24. 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
- Traditional
- 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.