Seal Single-Use Biopsy Valve
FDA 510(k) K161167 · Endochoice, Inc.
510(k) numberK161167
Submission
- Device name
- Seal Single-Use Biopsy Valve
- Applicant
- Endochoice, Inc.
Alpharetta, GA, US - Received
- April 26, 2016
- Decision date
- May 26, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Other 510(k)s with product code OCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
| K251997 | Single-Use Biopsy Valve (MAJ-1555)OCX · Traditional | Olympus Medical Systems Corporation | 09/25/2025SE |
| K242586 | ArgoCap (200.52)OCX · Traditional | Ovesco Endoscopy AG | 05/22/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/20/2025SE |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902)OCX · Traditional | Olympus Medical Systems Corporation | 10/07/2024SE |
| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
| K242134 | ClearCap Distal AttachmentOCX · Special | Finemedix Co., Ltd. | 08/20/2024SE |
| K233442 | troCarWash SystemOCX · Traditional | Biotex, Inc. | 05/21/2024SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
More from Zhejiang Chuangxiang Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox ProcessorPEA · Traditional | 08/01/2016SE |
| K161482 | EndoChoice Water Bottle Cap Irrigation SystemFEQ · Special | 06/27/2016SE |
| K160403 | SmartStart Air/Water and Suction ValvesODC · Traditional | 05/19/2016SE |
| K153588 | EndoChoice Water Bottle Cap SystemFEQ · Special | 02/24/2016SE |
| K151475 | EndoChoice Select Injection NeedleFBK · Traditional | 02/08/2016SE |
| K152182 | Fuse Gastroscopy SystemFDS · Special | 12/10/2015SE |
| K152580 | rescuenetFDI · Traditional | 11/03/2015SE |
| K142155 | Endochoice Water Bottle Cap SystemFEQ · Traditional | 01/20/2015SE |
| K140472 | Bonastent Tracheal / BronchialJCT · Traditional | 10/17/2014SE |
| K141598 | Fuse Colonoscopy SystemFDF · Special | 09/30/2014SE |
Questions and answers
When was Seal Single-Use Biopsy Valve cleared by the FDA?
Seal Single-Use Biopsy Valve (K161167) received a 510(k) decision of Substantially Equivalent on May 26, 2016, 30 days after the submission was received.
What is the product code of K161167?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.