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FEN — Device, Cystometric, Hydraulic Class II

FDA Device Classification

FDA product code FEN covers "Device, Cystometric, Hydraulic", a Class II medical device regulated under 21 CFR 876.1620. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FEN
Device Class
Class II
Regulation Number
876.1620
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K212830srs medicalCT3000ProDecember 21, 2021
K082701urodynamix technologiesURONIRS, MODEL 2000December 18, 2008
K073552laborie medical technologiesLABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYMarch 5, 2008
K001386pelvicareACCUSET SENSOR, MODEL 2000July 17, 2000
K992715medtronic functional diagnosticsNEURO URODYNAMIC SUITE, MODEL 9032E0101February 28, 2000
K983325influenceIN-PROBE II URODYNAMIC SYSTEMNovember 24, 1998
K970595circon videoCIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMPOctober 24, 1997
K971911medamicusLUMAX CYSTOMETRY ADMINISTRATION TUBE SETJune 3, 1997
K964522andromeda medizinische systemeELLIPSE 4March 21, 1997
K960503dantec medicalDANTEC DUETSeptember 16, 1996
K953734medamicusLUMAX(MODIFICATION)January 18, 1996
K954093medamicusLUMAX (MODIFICATION)January 11, 1996
K954315life-tech intlPVC ABDOMINAL/RECTAL PRESSURE CATHETERNovember 30, 1995
K954341life-tech intlURODYNAMICS TUBING AND INFUSION SETSOctober 17, 1995
K953451life-tech intlUROPUMP TUBE & DAMPING CHAMGEROctober 5, 1995
K953353life-tech intlUROVISION JANUSSeptember 8, 1995
K951805laborie medical technologiesPIPER, MODEL NUMBER UDS-PIPERBJuly 6, 1995
K952573rusch intlRUSCH URODYNAMIC RECTAL BALLOON CATHETERJune 15, 1995
K952029rusch intlRUSCH INTERNATIONAL URODYNAMIC CATHETERSJune 13, 1995
K945753fiberoptic sensor technlogiesFST FIBEROPTIC PRESSURE CONVERTERMay 11, 1995

FDA data resources