FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
K Number: K090851
·
Decision Jul 2, 2009
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
71
Applicant Total
12
Review Days
94
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Basic Information
- Device Name
- DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
- K Number
- K090851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Byrne Medical, Inc.
- Date Received
- March 30, 2009
- Decision Date
- July 2, 2009
- Product Code
- ODC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Byrne Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | Jun 20, 2012 | Substantially Equivalent |
| K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | Apr 27, 2012 | Substantially Equivalent |
| K102855 | UNIVERSAL IRRIGATION SOLUTION HYBRID | Nov 19, 2010 | Substantially Equivalent |
| K102581 | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 | Nov 8, 2010 | Substantially Equivalent |
| K102409 | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 | Nov 4, 2010 | Substantially Equivalent |
| K093665 | ENDO SMARTCAP | Dec 15, 2009 | Substantially Equivalent |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | Nov 30, 2009 | Substantially Equivalent |
| K092429 | ENDOGATOR | Nov 19, 2009 | Substantially Equivalent |
| K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | Apr 19, 2006 | Substantially Equivalent |
| K033695 | IRRIGATION CHANNEL TUBING, MODEL 100135 | Dec 23, 2003 | Substantially Equivalent |