Product code FEN
- Device name
- Device, Cystometric, Hydraulic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1620
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212830 | CT3000Pro | Srs Medical | 2021-12-21 |
| K082701 | URONIRS, MODEL 2000 | Urodynamix Technologies, Ltd. | 2008-12-18 |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | Laborie Medical Technologies, Corp. | 2008-03-05 |
| K001386 | ACCUSET SENSOR, MODEL 2000 | Pelvicare, Inc. | 2000-07-17 |
| K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | Medtronic Functional Diagnostics A/S | 2000-02-28 |
| K983325 | IN-PROBE II URODYNAMIC SYSTEM | Influence, Inc. | 1998-11-24 |
| K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | Circon Video | 1997-10-24 |
| K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET | Medamicus, Inc. | 1997-06-03 |
| K964522 | ELLIPSE 4 | Andromeda Medizinische Systeme GmbH | 1997-03-21 |
| K960503 | DANTEC DUET | Dantec Medical, Inc. | 1996-09-16 |
| K953734 | LUMAX(MODIFICATION) | Medamicus, Inc. | 1996-01-18 |
| K954093 | LUMAX (MODIFICATION) | Medamicus, Inc. | 1996-01-11 |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Life-Tech Intl., Inc. | 1995-11-30 |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Life-Tech Intl., Inc. | 1995-10-17 |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Life-Tech Intl., Inc. | 1995-10-05 |
| K953353 | UROVISION JANUS | Life-Tech Intl., Inc. | 1995-09-08 |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Laborie Medical Technologies, Ltd. | 1995-07-06 |
| K952573 | RUSCH URODYNAMIC RECTAL BALLOON CATHETER | Rusch Intl. | 1995-06-15 |
| K952029 | RUSCH INTERNATIONAL URODYNAMIC CATHETERS | Rusch Intl. | 1995-06-13 |
| K945753 | FST FIBEROPTIC PRESSURE CONVERTER | Fiberoptic Sensor Technlogies, Inc. | 1995-05-11 |
| K950908 | FST CATH-UD, CATHETER | Fiberoptic Sensor Technlogies, Inc. | 1995-04-07 |
| K950016 | CART, MODE NUMBER UDS-CART | Laborie Medical Tech Corp. | 1995-03-30 |
| K944391 | OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM | Surgitek | 1995-02-07 |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Laborie Medical Technologies, Ltd. | 1994-07-12 |
| K936041 | UROGRAM CYSTOMETROGRAM | Myo/Kinetic Systems, Inc. | 1994-04-18 |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Life-Tech Intl., Inc. | 1994-03-30 |
| K934141 | STAND ALONE CYSTOMETROGRAM | Medical Engineering Corp. | 1993-11-18 |
| K930171 | FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR | Fiberoptic Sensor Technlogies, Inc. | 1993-11-04 |
| K933399 | KENDALL URODYNAMIC CATHETERS | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-11-02 |
| K930135 | SILICONE RECTAL BALLOON | Cook Urological, Inc. | 1993-10-08 |
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| 08717775954941 | Solar Biofeedback system | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954934 | Solar Uroflow system | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954910 | Solar Gold L4, Trolley system | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954903 | Solar Silver BD, Trolley system | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954897 | Solar Silver L4, Trolley system | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954880 | Solar Smart BD, Pole mounted | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954873 | Solar Blue-Luna, Laptop integrated | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954866 | Solar Blue, Laptop integrated | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954859 | Solar Blue-Luna, Table top | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775954927 | Solar Gold BD, Trolley system | Medical Measurement Systems B.V. | 2016-09-23 |
| 10627825007051 | 2-lumen Catheter for Abdominal Pressure | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825007044 | 1-lumen Catheter for Abdominal Pressure | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825007020 | Extension Set 2 | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825007013 | 4 Ch. Single Use Anorectal Manometry Catheter-Stag | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825006993 | 4 Ch. Single Use Anorectal Manometry Catheter-Radi | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825006986 | 8 Ch. Single Use Anorectal Manometry Catheter | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825006962 | Pump Tube Set for Andromeda | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 10627825006955 | Infusion set for Cavernosometry | Laborie Medical Technologies Canada ULC | 2016-09-21 |
| 08718122046302 | e∙Sense | PendraCare International B.V. | 2016-05-01 |
| 08718122046296 | e∙Sense | PendraCare International B.V. | 2016-05-01 |
| 08718122028339 | e∙Sense | PendraCare International B.V. | 2016-05-01 |
| 08718122028322 | e∙Sense | PendraCare International B.V. | 2016-05-01 |
| 08718122028315 | e∙Sense | PendraCare International B.V. | 2016-05-01 |