Orca Air/Water and Suction Valves
FDA 510(k) K252910 · Boston Scientific
510(k) numberK252910
Submission
- Device name
- Orca Air/Water and Suction Valves
- Applicant
- Boston Scientific
Marlboro, MA, US - Received
- September 12, 2025
- Decision date
- October 9, 2025
- Decision
- Unknown (SESK)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
Other 510(k)s with product code ODC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252933 | Dyne PortODC · Traditional | Dyne Medical Group, Inc. | 06/12/2026SE |
| K250145 | Biopsy Port AdapterODC · Traditional | Endosound, Inc. | 10/17/2025SE |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)ODC · Traditional | Olympus Medical Systems Corporation | 07/16/2025SE |
| K250732 | Disposable Endoscopy Valve SetODC · Traditional | Yangzhou Fartley Medical Instrument Technology… | 06/20/2025SE |
| K241842 | Luer-Split MAJ-2092ODC · Traditional | Olympus Medical Systems Corporation | 03/19/2025SE |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning AdapterODC · Special | Steris Corparation | 02/20/2025SE |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…ODC · Special | STERIS Corporation | 11/08/2024SE |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC · Special | STERIS Corporation | 10/11/2024SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 10/01/2024SE |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use…ODC · Traditional | Medivators (A Subsidiary of Steris Corporation) | 03/22/2024SE |
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| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | 08/21/2026SE |
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| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was Orca Air/Water and Suction Valves cleared by the FDA?
Orca Air/Water and Suction Valves (K252910) received a 510(k) decision of Unknown on October 9, 2025, 27 days after the submission was received.
What is the product code of K252910?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.