EXY — Uroflowmeter Class II
FDA product code EXY covers "Uroflowmeter", a Class II medical device regulated under 21 CFR 876.1800. Submissions are reviewed by the Gastroenterology, Urology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EXY
- Device Class
- Class II
- Regulation Number
- 876.1800
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142425 | be technologies | Uroflowmeter | October 27, 2014 |
| K022721 | w.o.m. world of medicine | UROPOWER | August 26, 2003 |
| K971913 | albyn medical | GR100F URINE FLOWMETER | September 19, 1997 |
| K953999 | dantec medical | DANTEC DA CAPO | November 21, 1995 |
| K951442 | synectics medical | FLOLAB | August 24, 1995 |
| K944972 | myo/kinetic systems | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | March 8, 1995 |
| K945495 | fiberoptic sensor technlogies | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | February 9, 1995 |
| K941105 | laborie medical tech | UORCAP,MODEL NUMBER UDS-UCAP | May 10, 1994 |
| K904557 | life-tech intl | MICROFLO | December 28, 1990 |
| K902408 | diagnostic ultrasound | DIAGNOSTIC ULTRASOUND UFS 1005 | August 10, 1990 |
| K900770 | biodan medical systems | HOME URODATA SYSTEM(TM) | June 8, 1990 |
| K894968 | eutectic electronics | ULTRACOMPACT | November 8, 1989 |
| K880504 | mct medical | MCT MEDICAL BROWNE UROSCAN URODYNAMIC | June 17, 1988 |
| K873695 | life-tech intl | MODEL 1859 TUMI/PRESSURE MODULE | January 27, 1988 |
| K872077 | life-tech intl | MODEL 1858 CAVRO/PRESSURE MODULE | August 27, 1987 |
| K770897 | life-tech instruments | URODYNAMIC INSTRUMENTS | June 3, 1977 |