Orca Air/Water and Suction Valves
FDA 510(k) clearance K252910 · decided 2025-10-09
Clearance details
- K-number
- K252910
- Device name
- Orca Air/Water and Suction Valves
- Applicant
- Boston Scientific
- Decision
- Unknown
- Date received
- 2025-09-12
- Decision date
- 2025-10-09
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- ODC
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca A recall (Z-2413-2026) | Boston Scientific Corporation | 2026-06-11 |