510(k) K252910 ยท ODC Endoscope Channel Accessory
Orca Air/Water and Suction Valves
| Applicant | Boston Scientific, Marlboro MA, US |
| Decision | Unknown, Oct 9, 2025 |
| Received | Sep 12, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2026 | Boston Scientific Corporation Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastroint Open, Classified |
ODC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.