Medline Biopsy Valve
FDA 510(k) K131426 · Medline Industries, Inc.
510(k) numberK131426
Submission
- Device name
- Medline Biopsy Valve
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- May 17, 2013
- Decision date
- February 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
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| 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 |
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| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
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| 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 |
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Questions and answers
When was Medline Biopsy Valve cleared by the FDA?
Medline Biopsy Valve (K131426) received a 510(k) decision of Substantially Equivalent on February 21, 2014, 280 days after the submission was received.
What is the product code of K131426?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.