AMSCO CHIMERON MEDIUM STEAM STERLILZER— 510(k) K112403
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K112403 for AMSCO CHIMERON MEDIUM STEAM STERLILZER, Substantially Equivalent on 2012-05-08. 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
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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 →
Recalls naming K112403
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.