Product code EXY— Gastroenterology, Urology
4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
- Classification name
- Uroflowmeter
- Device class
- Class 2
- Regulation
- 21 CFR 876.1800
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code EXY
FDA has cleared devices under product code EXY between 1977 and 2014, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2014
- 2003
- 1997
- 1995
- 1994
- 1990
- 1989
- 1988
- 1987
- 1977
Top applicants under product code EXY
Recent clearances under product code EXY
- K142425 — Uroflowmeter
- K022721 — UROPOWER
- K971913 — GR100F URINE FLOWMETER
- K953999 — DANTEC DA CAPO
- K951442 — FLOLAB
- K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY
- K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
- K941105 — UORCAP,MODEL NUMBER UDS-UCAP
- K904557 — MICROFLO
- K902408 — DIAGNOSTIC ULTRASOUND UFS 1005
- K900770 — HOME URODATA SYSTEM(TM)
- K894968 — ULTRACOMPACT
- K880504 — MCT MEDICAL BROWNE UROSCAN URODYNAMIC
- K873695 — MODEL 1859 TUMI/PRESSURE MODULE
- K872077 — MODEL 1858 CAVRO/PRESSURE MODULE
- K770897 — URODYNAMIC INSTRUMENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.