ENDOGATOR Hybrid Irrigation Tubing
FDA 510(k) K231418 · Medivators
510(k) numberK231418
Submission
- Device name
- ENDOGATOR Hybrid Irrigation Tubing
- Applicant
- Medivators
Minneapolis, MN, US - Received
- May 16, 2023
- Decision date
- August 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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|---|---|---|---|
| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
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| 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 |
|---|---|---|
| K223040 | Endo SmartCapFAJ · Special | 03/01/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | 01/14/2022SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | 12/19/2017SE |
| K162128 | Scope Buddy Plus Endoscope Flushing AidFEB · Traditional | 12/21/2016SE |
| K160846 | AmplifEYEFED · Traditional | 07/14/2016SE |
| K152394 | Rapicide PA High-Level Disinfectant Test StripsJOJ · Traditional | 03/11/2016SE |
| K151522 | DEFENDO Bronchoscopy Suction ValveKTI · Traditional | 09/17/2015SE |
| K133724 | Minncare HDNIH · Traditional | 08/27/2014SE |
| K140753 | Endo Smart Bottle, Rinse and Insufflation SystemOCX · Special | 07/15/2014SE |
| K993042 | Medivators 5 Minute High-Level DisinfectantMED · Traditional | 08/17/2000SE |
Questions and answers
When was ENDOGATOR Hybrid Irrigation Tubing cleared by the FDA?
ENDOGATOR Hybrid Irrigation Tubing (K231418) received a 510(k) decision of Substantially Equivalent on August 14, 2023, 90 days after the submission was received.
What is the product code of K231418?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.