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Endovations

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
38
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K955413ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETERFebruary 8, 1996
K942110INJECT-SNAREOctober 13, 1994
K944049OXYGEN MOUTHGUARDOctober 11, 1994
K934315ENDOVATIONS(R) .035 PRE-CUT PAPILLATOMEFebruary 28, 1994
K9138412 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATHOctober 8, 1991
K9138705MM MICROSCISSORSSeptember 16, 1991
K911155OVAL CUP BIOPSY FORCEPAugust 7, 1991
K892218ENDO-SPONGEMay 31, 1989
K883093TRANSENDOSCOPIC ASPIRATION NEEDLEDecember 8, 1988
K873360ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEGMarch 30, 1988
K875264WASHING CATHETERMarch 29, 1988
K874062ENTERON LIVER BIOPSY TRAYDecember 31, 1987
K874011OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)December 29, 1987
K874014OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)December 29, 1987
K874009OVAL CUP HOT BIOPSY FORCEP (MODEL C-52)December 29, 1987
K874007OVAL CUP HOT BIOPSY FORCEP (MODEL A-51)December 29, 1987
K874006GRASPING TRIPOD FORCEP (MODEL 23/25)December 29, 1987
K874016OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDODecember 29, 1987
K874012OVAL CUP BIOPSY FORCEP (MODEL 18/5)December 29, 1987
K874008OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)December 29, 1987