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.
Summary
STERIS Corporation's AMSCO 700 Steam Sterilizer is filed under FLE, steam sterilizers. The record doesn't give chamber sizes or configurations.
Class II, 21 CFR 880.6880. General Hospital is both the classification panel and the review panel. The submission was a Traditional 510(k).
STERIS filed from Mentor, Ohio. The decision came 85 calendar days after receipt (March 31 to June 24, 2026).
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Product 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.