FAP · Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Gastroenterology, Urology · 21 CFR 876.1620 · Class 2
Overview
| Product Code | FAP |
|---|---|
| Device Name | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device |
| 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 85)
Showing 20 most recent of 85 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113771 | SIGNAL GEAR URETHRAL CATHETER ELECTRODE | Neurovision Medical Products, Inc. | Dec 13, 2012 | SESE |
| K974775 | SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE | Airtronic Services, Inc. | Feb 19, 1998 | SESE |
| K963330 | URODYNAMIC ANALYSIS MODULE | Synectics Medical, Inc. | Apr 3, 1997 | SESE |
| K962472 | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER | Rusch Intl. | Aug 27, 1996 | SESE |
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE | Sandhill Scientific, Inc. | Apr 1, 1994 | SESE |
| K931179 | UROLAB SPECTRUM | Life-Tech Intl., Inc. | Nov 18, 1993 | SESE |
| K922476 | URO-PRO 2000 | Fiberoptic Sensor Technlogies, Inc. | Jul 20, 1993 | SESE |
| K924383 | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO | Synectics-Dantec | Jun 18, 1993 | SESE |
| K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 | Advanced Medical Products, Inc. | Apr 8, 1993 | SESE |
| K923464 | URODYNAMIC CATHETERS | R.L. Medical Corp. | Feb 5, 1993 | SESE |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Laborie Medical Technologies, Ltd. | Oct 20, 1992 | SESE |
| K920451 | ENDOTEK ULTRA SYSTEM | Surgitek | Sep 17, 1992 | SESE |
| K920777 | LABORIE URODYNAMICS PROCESSOR | R. Laborie Surgical , Ltd. | Sep 4, 1992 | SESE |
| K920575 | MERKUR 4000 | F.M. Wiest USA, Inc. | Jul 23, 1992 | SESE |
| K914300 | PHOENIX 5 URODYNAMICS SYSTEM | Aspen Medical , Ltd. | Jun 2, 1992 | SESE |
| K921047 | MODEL 8100 URODYNAMICS MEASURING SYSTEM | Browne Medical Systems, Inc. | Apr 10, 1992 | SESE |
| K920992 | PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED | Browne Medical Systems, Inc. | Apr 10, 1992 | SESE |
| K920991 | IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION | Browne Medical Systems, Inc. | Apr 10, 1992 | SESE |
| K915484 | URETHRALPRESSURE PROFILE CATHETER | Life-Tech Intl., Inc. | Feb 24, 1992 | SESE |
| K915443 | URODYNAMIC CATHETER | Cook Urological, Inc. | Feb 19, 1992 | SESE |
Top Applicants
- Life-Tech Intl., Inc. — 14 clearances
- Browne Corp. — 7 clearances
- Browne Medical Systems, Inc. — 7 clearances
- Dantec Medical, Inc. — 6 clearances
- Warne Surgical Products, Ltd. — 4 clearances
