Product code EXY
- Device name
- Uroflowmeter
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1800
- 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 |
|---|---|---|---|
| K142425 | Uroflowmeter | Be Technologies, Inc. | 2014-10-27 |
| K022721 | UROPOWER | W.O.M. World of Medicine AG | 2003-08-26 |
| K971913 | GR100F URINE FLOWMETER | Albyn Medical , Ltd. | 1997-09-19 |
| K953999 | DANTEC DA CAPO | Dantec Medical, Inc. | 1995-11-21 |
| K951442 | FLOLAB | Synectics Medical, Inc. | 1995-08-24 |
| K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | Myo/Kinetic Systems, Inc. | 1995-03-08 |
| K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | Fiberoptic Sensor Technlogies, Inc. | 1995-02-09 |
| K941105 | UORCAP,MODEL NUMBER UDS-UCAP | Laborie Medical Tech, Inc. | 1994-05-10 |
| K904557 | MICROFLO | Life-Tech Intl., Inc. | 1990-12-28 |
| K902408 | DIAGNOSTIC ULTRASOUND UFS 1005 | Diagnostic Ultrasound Corp. | 1990-08-10 |
| K900770 | HOME URODATA SYSTEM(TM) | Biodan Medical Systems, Ltd. | 1990-06-08 |
| K894968 | ULTRACOMPACT | Eutectic Electronics, Inc. | 1989-11-08 |
| K880504 | MCT MEDICAL BROWNE UROSCAN URODYNAMIC | Mct Medical, Inc. | 1988-06-17 |
| K873695 | MODEL 1859 TUMI/PRESSURE MODULE | Life-Tech Intl., Inc. | 1988-01-27 |
| K872077 | MODEL 1858 CAVRO/PRESSURE MODULE | Life-Tech Intl., Inc. | 1987-08-27 |
| K770897 | URODYNAMIC INSTRUMENTS | Life-Tech Instruments, Inc. | 1977-06-03 |
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| 00086000980061 | Glean | Bright Uro, Inc | 2025-09-23 |
| 00860009800601 | Glean | Bright Uro, Inc | 2025-09-23 |
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