UROGRAM CYSTOMETROGRAM
Device Facts
| Record ID | K936041 |
|---|---|
| Device Name | UROGRAM CYSTOMETROGRAM |
| Applicant | Myo/Kinetic Systems, Inc. |
| Product Code | FEN · Gastroenterology, Urology |
| Decision Date | Apr 18, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1620 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
