FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Orca Air/Water and Suction Valves
K Number: K252910
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
71
Applicant Total
58
Review Days
27
Basic Information
- Device Name
- Orca Air/Water and Suction Valves
- K Number
- K252910
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- September 12, 2025
- Decision Date
- October 9, 2025
- Product Code
- ODC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | FDA class 2 | Gastroenterology, Urology |
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