K252910 is an FDA 510(k) clearance for the Orca Air/Water and Suction Valves. This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by Boston Scientific (Marlboro, US). The FDA issued a Cleared decision on October 9, 2025, 27 days after receiving the submission on September 12, 2025.
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 | K252910 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | September 12, 2025 |
| Decision Date | October 09, 2025 |
| Days to Decision | 27 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. |