Endogator Advantage Irrigation Pump
FDA 510(k) K113119 · Byrne Medical, Inc.
510(k) numberK113119
Submission
- Device name
- Endogator Advantage Irrigation Pump
- Applicant
- Byrne Medical, Inc.
Minneapolis, MN, US - Received
- October 21, 2011
- Decision date
- April 27, 2012
- 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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| 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 |
|---|---|---|
| K113310 | Endogater Avantage CO2 InsufflatorFCX · Traditional | 06/20/2012SE |
| K110088 | Defendo Y-Opsy IrrigatorODC · Traditional | 06/10/2011SE |
| K102855 | Universal Irrigation Solution HybridOCX · Traditional | 11/19/2010SE |
| K102581 | Defendo Disposable Suction Valve Model 100305ODC · Traditional | 11/08/2010SE |
| K102409 | Defendo Disposable Air/Water Valve Model 100304ODC · Traditional | 11/04/2010SE |
| K093665 | Endo SmartcapFAJ · Traditional | 12/15/2009SE |
| K092090 | Erbelift Hand Pump and Flexible ProbeFBK · Traditional | 11/30/2009SE |
| K092429 | EndogatorFEQ · Traditional | 11/19/2009SE |
| K090851 | Defendo (TM) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301…ODC · Traditional | 07/02/2009SE |
| K060962 | Endogator Endoscopy Irrigation Pump, Model EGP-100OCX · Traditional | 04/19/2006SE |
Questions and answers
When was Endogator Advantage Irrigation Pump cleared by the FDA?
Endogator Advantage Irrigation Pump (K113119) received a 510(k) decision of Substantially Equivalent on April 27, 2012, 189 days after the submission was received.
What is the product code of K113119?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.