Defendo Y-Opsy Irrigator
FDA 510(k) K110088 · Byrne Medical Incorporated
510(k) numberK110088
Submission
- Device name
- Defendo Y-Opsy Irrigator
- Applicant
- Byrne Medical Incorporated
Conroe, TX, US - Received
- January 12, 2011
- Decision date
- June 10, 2011
- 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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| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC · Special | STERIS Corporation | 10/11/2024SE |
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More from Alton (Shanghai) Medical Instruments Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K113310 | Endogater Avantage CO2 InsufflatorFCX · Traditional | 06/20/2012SE |
| K113119 | Endogator Advantage Irrigation PumpOCX · Traditional | 04/27/2012SE |
| 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 Defendo Y-Opsy Irrigator cleared by the FDA?
Defendo Y-Opsy Irrigator (K110088) received a 510(k) decision of Substantially Equivalent on June 10, 2011, 149 days after the submission was received.
What is the product code of K110088?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.