Novasys Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K042132NOVASYS TRANSURETHRAL RF SYSTEMDecember 21, 2004
K013730ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIESFebruary 6, 2002
K001328INTRODUCER SHEATHJuly 17, 2000
K001150ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHJune 29, 2000
K001151ELECTROSURGICAL ELECTRODE FAMILYJune 27, 2000