Defendo (TM) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301, Defendo(Tm) Biopsy Valve for Pentax(R)
FDA 510(k) K090851 · Byrne Medical, Inc.
510(k) numberK090851
Submission
- Device name
- Defendo (TM) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301, Defendo(Tm) Biopsy Valve for Pentax(R)
- Applicant
- Byrne Medical, Inc.
Conroe, TX, US - Received
- March 30, 2009
- Decision date
- July 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
Other 510(k)s with product code ODC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252933 | Dyne PortODC · Traditional | Dyne Medical Group, Inc. | 06/12/2026SE |
| K250145 | Biopsy Port AdapterODC · Traditional | Endosound, Inc. | 10/17/2025SE |
| K252910 | Orca Air/Water and Suction ValvesODC · Special | Boston Scientific | 10/09/2025SESK |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)ODC · Traditional | Olympus Medical Systems Corporation | 07/16/2025SE |
| K250732 | Disposable Endoscopy Valve SetODC · Traditional | Yangzhou Fartley Medical Instrument Technology… | 06/20/2025SE |
| K241842 | Luer-Split MAJ-2092ODC · Traditional | Olympus Medical Systems Corporation | 03/19/2025SE |
| K250140 | Defendo Fujifilm 700 Single Use Cleaning AdapterODC · Special | Steris Corparation | 02/20/2025SE |
| K243075 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096…ODC · Special | STERIS Corporation | 11/08/2024SE |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)ODC · Special | STERIS Corporation | 10/11/2024SE |
| K241285 | Disposable Endoscope Valves Set (AF series)ODC · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 10/01/2024SE |
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 |
| 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 |
| K060962 | Endogator Endoscopy Irrigation Pump, Model EGP-100OCX · Traditional | 04/19/2006SE |
Questions and answers
When was Defendo (TM) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301, Defendo(Tm) Biopsy Valve for Pentax(R) cleared by the FDA?
Defendo (TM) Biopsy Valve for Olympus(R) and Fujinon(R) Endoscopes, Model 100301, Defendo(Tm) Biopsy Valve for Pentax(R) (K090851) received a 510(k) decision of Substantially Equivalent on July 2, 2009, 94 days after the submission was received.
What is the product code of K090851?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.