enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System— 510(k) K243433
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K243433 for enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System, Substantially Equivalent on 2024-12-02. Applicant: STERIS Corporation.
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Code FEB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Adverse events under product code FEB
product code FEB- Malfunction
- 3,879
- Total
- 3,879
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.