Biopsy Port Adapter
FDA 510(k) K250145 · Endosound, Inc.
510(k) numberK250145
Submission
- Device name
- Biopsy Port Adapter
- Applicant
- Endosound, Inc.
Portland, OR, US - Received
- January 21, 2025
- Decision date
- October 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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| 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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| K232518 | EndoSound Vision System; EVSODG · Traditional | 12/27/2023SE |
Questions and answers
When was Biopsy Port Adapter cleared by the FDA?
Biopsy Port Adapter (K250145) received a 510(k) decision of Substantially Equivalent on October 17, 2025, 269 days after the submission was received.
What is the product code of K250145?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.