Cystometer, Electrical Recording
The electrical recording cystometer is a diagnostic device that measures the pressure-volume relationship of the urinary bladder during filling and voiding to assess bladder function, compliance, and capacity, supporting the diagnosis of voiding dysfunction and neurogenic bladder. It is classified as FDA Class 2, indicating moderate risk and requiring special controls. The product code is EXQ, regulated under 21 CFR 876.1620 in the Gastroenterology, Urology specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- EXQ
- Device Class
- FDA class 2
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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) | Apr 16, 2026 | Substantially Equivalent | Bright Uro, Inc. |
| 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)) | Mar 24, 2025 | Substantially Equivalent | Bright Uro, Inc. |
| K931282 | VOLUME TRANSDUCER | Sep 17, 1993 | Substantially Equivalent | Life-Tech Intl., Inc. |
| K931574 | ADVANCE MODEL UDS-ADV | Aug 05, 1993 | Substantially Equivalent | Laborie Medical Technologies, Ltd. |
| K920574 | CAMSYS 6300 | Feb 17, 1993 | Substantially Equivalent | F.M. Wiest USA, Inc. |
| K880391 | DACOMED CYSTOMETER | Apr 27, 1988 | Substantially Equivalent | Dacomed Corp. |
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Sep 09, 1981 | Substantially Equivalent | Life-Tech Instruments, Inc. |
| K781032 | AQUA-GEL | Dec 15, 1978 | Substantially Equivalent | Murray, Salk, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.