Product code EXQ
- Device name
- Cystometer, Electrical Recording
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1620
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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-100... | Bright Uro, Inc. | 2026-04-16 |
| 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. | 2025-03-24 |
| K931282 | VOLUME TRANSDUCER | Life-Tech Intl., Inc. | 1993-09-17 |
| K931574 | ADVANCE MODEL UDS-ADV | Laborie Medical Technologies, Ltd. | 1993-08-05 |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | 1993-02-17 |
| K880391 | DACOMED CYSTOMETER | Dacomed Corp. | 1988-04-27 |
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Life-Tech Instruments, Inc. | 1981-09-09 |
| K781032 | AQUA-GEL | Murray, Salk, Inc. | 1978-12-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 00890477000395 | Tri-Electrode Surface EMG | SRS Medical Systems, Inc. | 2026-03-04 |
| 00890477000388 | EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) | SRS Medical Systems, Inc. | 2026-01-21 |
| 00890477000371 | EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) | SRS Medical Systems, Inc. | 2026-01-21 |
| 00860009800656 | Glean | Bright Uro, Inc | 2025-09-23 |
| 00860009800649 | Glean | Bright Uro, Inc | 2025-09-23 |
| 00860009800632 | Glean | Bright Uro, Inc | 2025-09-23 |
| 00860009800625 | Glean | Bright Uro, Inc | 2025-09-23 |
| 00860009800601 | Glean | Bright Uro, Inc | 2025-09-23 |
| 00086000980061 | Glean | Bright Uro, Inc | 2025-09-23 |
| 08032248487147 | Atmos | DELTA MED SPA | 2025-09-02 |
| 08032248487123 | Atmos | DELTA MED SPA | 2025-09-02 |
| 08032248487185 | Infusion Set | DELTA MED SPA | 2025-09-02 |
| 08032248490130 | Atmos | DELTA MED SPA | 2025-09-02 |
| E261MMT11730 | Infusion Set | BIOENGINEERING LABORATORIES SRL | 2024-12-09 |
| E261UDA462150 | Atmos | BIOENGINEERING LABORATORIES SRL | 2024-10-10 |
| E261UDA582450 | Atmos | BIOENGINEERING LABORATORIES SRL | 2024-09-03 |
| E261UDAELN0 | Atmos | BIOENGINEERING LABORATORIES SRL | 2024-09-03 |
| E261UDA362050 | Atmos | BIOENGINEERING LABORATORIES SRL | 2024-09-02 |
| 20814247021223 | Flowstar | Medical Measurement Systems B.V. | 2024-04-19 |
| 00890477000333 | UroCuff-DC Disposable, Single | SRS Medical Systems, Inc. | 2020-09-29 |
| 00890477000289 | Leak Pnt Det, Single | SRS Medical Systems, Inc. | 2018-12-24 |
| 00890477000265 | EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) | SRS Medical Systems, Inc. | 2018-12-24 |
| 00890477000319 | EP1 VP Test Pressure Kit, Single | SRS Medical Systems, Inc. | 2018-10-30 |
| 00890477000302 | EasyPro One | SRS Medical Systems, Inc. | 2018-06-25 |
| 00890477000135 | CT3000Plus Base Unit | SRS Medical Systems, Inc. | 2018-06-25 |
| 00890477000128 | EasyPro 4.1 Base Unit | SRS Medical Systems, Inc. | 2018-06-25 |
| M220P5495253 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| 08717775955917 | Solar Blue Module | Medical Measurement Systems B.V. | 2016-09-23 |
| 08717775955634 | Flowsensor3-BT | Medical Measurement Systems B.V. | 2016-09-23 |