AMSCO CHIMERON SMALL STEAM STERILIZER— 510(k) K111223
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K111223 for AMSCO CHIMERON SMALL STEAM STERILIZER, Substantially Equivalent on 2011-09-20. 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
- Abbreviated
- Location
- Mentor, OH, US
Recent devices under product code FLE
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view all- K251666 — SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700 +1 more
- K260766 — Celerity 5 HP Biological Indicator (LCB052)
- K252680 — Celerity 20 HP Biological Indicator
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K243876 — VERIFY STEAM Integrating Indicator
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 →
Recalls naming K111223
K-number listed on FDA's recall record- Z-0210-2016 — AMSCO 400 and AMSCO C Small Steam Sterilizers
- Z-1561-2015 — AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
- Z-0915-2013 — AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111223.
Data sourced from openFDA. This site is unofficial and independent of the FDA.