FEN — Device, Cystometric, Hydraulic Class II
FDA Device Classification
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-Number | Applicant | Device Name | Date |
| K212830 | srs medical | CT3000Pro | December 21, 2021 |
| K082701 | urodynamix technologies | URONIRS, MODEL 2000 | December 18, 2008 |
| K073552 | laborie medical technologies | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | March 5, 2008 |
| K001386 | pelvicare | ACCUSET SENSOR, MODEL 2000 | July 17, 2000 |
| K992715 | medtronic functional diagnostics | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | February 28, 2000 |
| K983325 | influence | IN-PROBE II URODYNAMIC SYSTEM | November 24, 1998 |
| K970595 | circon video | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | October 24, 1997 |
| K971911 | medamicus | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET | June 3, 1997 |
| K964522 | andromeda medizinische systeme | ELLIPSE 4 | March 21, 1997 |
| K960503 | dantec medical | DANTEC DUET | September 16, 1996 |
| K953734 | medamicus | LUMAX(MODIFICATION) | January 18, 1996 |
| K954093 | medamicus | LUMAX (MODIFICATION) | January 11, 1996 |
| K954315 | life-tech intl | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | November 30, 1995 |
| K954341 | life-tech intl | URODYNAMICS TUBING AND INFUSION SETS | October 17, 1995 |
| K953451 | life-tech intl | UROPUMP TUBE & DAMPING CHAMGER | October 5, 1995 |
| K953353 | life-tech intl | UROVISION JANUS | September 8, 1995 |
| K951805 | laborie medical technologies | PIPER, MODEL NUMBER UDS-PIPERB | July 6, 1995 |
| K952573 | rusch intl | RUSCH URODYNAMIC RECTAL BALLOON CATHETER | June 15, 1995 |
| K952029 | rusch intl | RUSCH INTERNATIONAL URODYNAMIC CATHETERS | June 13, 1995 |
| K945753 | fiberoptic sensor technlogies | FST FIBEROPTIC PRESSURE CONVERTER | May 11, 1995 |