K232004 is an FDA 510(k) clearance for the Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector. This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by Medivators (A Subsidiary of Steris Corporation) (Conroe, US). The FDA issued a Cleared decision on March 6, 2024, 244 days after receiving the submission on July 6, 2023.
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 | K232004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2023 |
| Decision Date | March 06, 2024 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| 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. |