EXQ · Cystometer, Electrical Recording
Gastroenterology, Urology · 21 CFR 876.1620 · Class 2
Overview
| Product Code | EXQ |
|---|---|
| Device Name | Cystometer, Electrical Recording |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | Bright Uro, Inc. | Apr 16, 2026 | SESE |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) | Bright Uro, Inc. | Mar 24, 2025 | SESE |
| K931282 | VOLUME TRANSDUCER | Life-Tech Intl., Inc. | Sep 17, 1993 | SESE |
| K931574 | ADVANCE MODEL UDS-ADV | Laborie Medical Technologies, Ltd. | Aug 5, 1993 | SESE |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | Feb 17, 1993 | SESE |
| K880391 | DACOMED CYSTOMETER | Dacomed Corp. | Apr 27, 1988 | SESE |
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Life-Tech Instruments, Inc. | Sep 9, 1981 | SESE |
| K781032 | AQUA-GEL | Murray, Salk, Inc. | Dec 15, 1978 | SESE |
Top Applicants
- Bright Uro, Inc. — 2 clearances
- Dacomed Corp. — 1 clearance
- F.M. Wiest USA, Inc. — 1 clearance
- Laborie Medical Technologies, Ltd. — 1 clearance
- Life-Tech Instruments, Inc. — 1 clearance
