Device, Cystometric, Hydraulic
FDA product code FEN · Class II (moderate risk) · 21 CFR 876.1620 · Gastroenterology, Urology
36510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Fiberoptic Sensor Technlogies, Inc. 8
- Life-Tech Intl., Inc. 5
- Laborie Medical Technologies, Ltd. 3
- Medamicus, Inc. 3
- Rusch Intl. 2
- Srs Medical 1
- Urodynamix Technologies, Ltd. 1
- Pelvicare, Inc. 1
- Medtronic Functional Diagnostics A/S 1
- Influence, Inc. 1
- Circon Video 1
- Andromeda Medizinische Systeme GmbH 1
- Dantec Medical, Inc. 1
- Laborie Medical Tech Corp. 1
- Surgitek 1
- Myo/Kinetic Systems, Inc. 1
- Medical Engineering Corp. 1
- Kendall Healthcare Products Co. Div.Of Tyco Health 1
- Cook Urological, Inc. 1
- C.R. Bard, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212830 | CT3000ProFEN · Traditional | Srs Medical | 12/21/2021SE |
| K082701 | Uronirs, Model 2000FEN · Traditional | Urodynamix Technologies, Ltd. | 12/18/2008SE |
| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | Laborie Medical Technologies, Corp. | 03/05/2008SE |
| K001386 | Accuset Sensor, Model 2000FEN · Traditional | Pelvicare, Inc. | 07/17/2000SE |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional | Medtronic Functional Diagnostics A/S | 02/28/2000SE |
| K983325 | In-Probe II Urodynamic SystemFEN · Traditional | Influence, Inc. | 11/24/1998SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | Circon Video | 10/24/1997SE |
| K971911 | Lumax Cystometry Administration Tube SetFEN · Traditional | Medamicus, Inc. | 06/03/1997SE |
| K964522 | Ellipse 4FEN · Traditional | Andromeda Medizinische Systeme GmbH | 03/21/1997SE |
| K960503 | Dantec DuetFEN · Traditional | Dantec Medical, Inc. | 09/16/1996SE |
| K953734 | Lumax(Modification)FEN · Traditional | Medamicus, Inc. | 01/18/1996SE |
| K954093 | Lumax (Modification)FEN · Traditional | Medamicus, Inc. | 01/11/1996SE |
| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | Life-Tech Intl., Inc. | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | Life-Tech Intl., Inc. | 10/17/1995SE |
| K953451 | Uropump Tube & Damping ChamgerFEN · Traditional | Life-Tech Intl., Inc. | 10/05/1995SE |
| K953353 | Urovision JanusFEN · Traditional | Life-Tech Intl., Inc. | 09/08/1995SE |
| K951805 | Piper, Model Number Uds-PiperbFEN · Traditional | Laborie Medical Technologies, Ltd. | 07/06/1995SE |
| K952573 | Rusch Urodynamic Rectal Balloon CatheterFEN · Traditional | Rusch Intl. | 06/15/1995SE |
| K952029 | Rusch International Urodynamic CathetersFEN · Traditional | Rusch Intl. | 06/13/1995SE |
| K945753 | FST Fiberoptic Pressure ConverterFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 05/11/1995SE |
| K950908 | FST Cath-Ud, CatheterFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 04/07/1995SE |
| K950016 | Cart, Mode Number Uds-CartFEN · Traditional | Laborie Medical Tech Corp. | 03/30/1995SE |
| K944391 | OM-4 (Tenative) Urodynamic Measruement SystemFEN · Traditional | Surgitek | 02/07/1995SE |
| K942023 | Infusion Pump, Model No. UDP-5FEN · Traditional | Laborie Medical Technologies, Ltd. | 07/12/1994SE |
| K936041 | Urogram CystometrogramFEN · Traditional | Myo/Kinetic Systems, Inc. | 04/18/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | Life-Tech Intl., Inc. | 03/30/1994SE |
| K934141 | Stand Alone CystometrogramFEN · Traditional | Medical Engineering Corp. | 11/18/1993SE |
| K930171 | FST Dual, Dual Pressure Urodynamics MonitorFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 11/04/1993SE |
| K933399 | Kendall Urodynamic CathetersFEN · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 11/02/1993SE |
| K930135 | Silicone Rectal BalloonFEN · Traditional | Cook Urological, Inc. | 10/08/1993SE |
| K924714 | Bard Urodynamic CatheterFEN · Traditional | C.R. Bard, Inc. | 09/21/1993SE |
| K922776 | FST Council Tip Foley CatheterFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 07/20/1993SE |
| K926088 | FST Cath Ud-Dual Dual Pressure CatheterFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 06/18/1993SE |
| K913113 | FST Cath-Ud Catheter, ModificationFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 10/09/1991SE |
| K913721 | FST Cath - Ui Usrodynamic Cath Introducer SystemFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 10/08/1991SE |
| K905641 | FST Cath-Ud CatheterFEN · Traditional | Fiberoptic Sensor Technlogies, Inc. | 02/19/1991SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2076-2019 Class II | U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for…Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end… | Laborie Medical Technologies, Corp | 07/17/2019Terminated |
| Z-2744-2018 Class II | AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a)…Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential… | ConvaTec, Inc | 07/03/2018Terminated |
| Z-0229-2007 | Laborie Transducer Cartridge with Luer Lock Reference: DIS130Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number.… | Laborie Medical Technologies | 10/04/2006Terminated |