Byrne Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ENDOGATER AVANTAGE CO2 INSUFFLATOR, ENDOGATOR ADVANTAGE IRRIGATION PUMP, DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Byrne Medical, Inc. Gastroenterology & Urology ✕
12 devices
Cleared
Jun 20, 2012
ENDOGATER AVANTAGE CO2 INSUFFLATOR
Gastroenterology & Urology
225d
Cleared
Apr 27, 2012
ENDOGATOR ADVANTAGE IRRIGATION PUMP
Gastroenterology & Urology
189d
Cleared
Nov 19, 2010
UNIVERSAL IRRIGATION SOLUTION HYBRID
Gastroenterology & Urology
51d
Cleared
Nov 08, 2010
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
Gastroenterology & Urology
61d
Cleared
Nov 04, 2010
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304
Gastroenterology & Urology
72d
Cleared
Dec 15, 2009
ENDO SMARTCAP
Gastroenterology & Urology
20d
Cleared
Nov 30, 2009
ERBELIFT HAND PUMP AND FLEXIBLE PROBE
Gastroenterology & Urology
139d
Cleared
Nov 19, 2009
ENDOGATOR
Gastroenterology & Urology
104d
Cleared
Jul 02, 2009
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL...
Gastroenterology & Urology
94d
Cleared
Apr 19, 2006
ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100
Gastroenterology & Urology
12d
Cleared
Dec 23, 2003
IRRIGATION CHANNEL TUBING, MODEL 100135
Gastroenterology & Urology
28d
Cleared
Jun 24, 2003
ENDO GATOR SYSTEM
Gastroenterology & Urology
15d