FEN · Device, Cystometric, Hydraulic
Gastroenterology, Urology · 21 CFR 876.1620 · Class 2
Overview
| Product Code | FEN |
|---|---|
| Device Name | Device, Cystometric, Hydraulic |
| Regulation | 21 CFR 876.1620 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K212830 | CT3000Pro | Srs Medical | Dec 21, 2021 | SESE |
| K082701 | URONIRS, MODEL 2000 | Urodynamix Technologies, Ltd. | Dec 18, 2008 | SESE |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | Laborie Medical Technologies, Corp. | Mar 5, 2008 | SESE |
| K001386 | ACCUSET SENSOR, MODEL 2000 | Pelvicare, Inc. | Jul 17, 2000 | SESE |
| K992715 | NEURO URODYNAMIC SUITE, MODEL 9032E0101 | Medtronic Functional Diagnostics A/S | Feb 28, 2000 | SESE |
| K983325 | IN-PROBE II URODYNAMIC SYSTEM | Influence, Inc. | Nov 24, 1998 | SESE |
| K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | Circon Video | Oct 24, 1997 | SESE |
| K971911 | LUMAX CYSTOMETRY ADMINISTRATION TUBE SET | Medamicus, Inc. | Jun 3, 1997 | SESE |
| K964522 | ELLIPSE 4 | Andromeda Medizinische Systeme GmbH | Mar 21, 1997 | SESE |
| K960503 | DANTEC DUET | Dantec Medical, Inc. | Sep 16, 1996 | SESE |
| K953734 | LUMAX(MODIFICATION) | Medamicus, Inc. | Jan 18, 1996 | SESE |
| K954093 | LUMAX (MODIFICATION) | Medamicus, Inc. | Jan 11, 1996 | SESE |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Life-Tech Intl., Inc. | Nov 30, 1995 | SESE |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Life-Tech Intl., Inc. | Oct 17, 1995 | SESE |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Life-Tech Intl., Inc. | Oct 5, 1995 | SESE |
| K953353 | UROVISION JANUS | Life-Tech Intl., Inc. | Sep 8, 1995 | SESE |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Laborie Medical Technologies, Ltd. | Jul 6, 1995 | SESE |
| K952573 | RUSCH URODYNAMIC RECTAL BALLOON CATHETER | Rusch Intl. | Jun 15, 1995 | SESE |
| K952029 | RUSCH INTERNATIONAL URODYNAMIC CATHETERS | Rusch Intl. | Jun 13, 1995 | SESE |
| K945753 | FST FIBEROPTIC PRESSURE CONVERTER | Fiberoptic Sensor Technlogies, Inc. | May 11, 1995 | SESE |
Top Applicants
- Fiberoptic Sensor Technlogies, Inc. — 8 clearances
- Life-Tech Intl., Inc. — 5 clearances
- Medamicus, Inc. — 3 clearances
- Laborie Medical Technologies, Ltd. — 2 clearances
- Rusch Intl. — 2 clearances
