K243075 is an FDA 510(k) clearance for the Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280). This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by STERIS Corporation (Minneapolis, US). The FDA issued a Cleared decision on November 8, 2024, 42 days after receiving the submission on September 27, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Give The Endoscope Channel Additional Or Improved Functionality..
| 510(k) Number | K243075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | November 08, 2024 |
| Days to Decision | 42 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODC — Endoscope Channel Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |