K243075
- 510(k) number
- K243075
- Device name
- Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
- Applicant
- STERIS Corporation MN · US
- Product code
- ODC — Endoscope Channel Accessory
- Decision date
- 2024-11-08
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K243075.pdf
Official FDA record: K243075
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.