510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EXYClass II

Uroflowmeter

21 CFR 876.1800 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EXY is the FDA product code for Uroflowmeter, a class II device type, regulated under 21 CFR 876.1800. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
EXY
Device name
Uroflowmeter
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
2

Clearances, product code EXY

By decision year
16 clearances under product code EXY with a decision year between 1977 and 2014, 1995 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EXY by decision year
YearClearances
19771
19871
19882
19891
19903
19941
19954
19971
20031
20141

Applicants with the most clearances

Product code EXY
Applicants holding the most 510(k) clearances under product code EXY
ApplicantClearances
Life-Tech Intl., Inc.3
Albyn Medical, Ltd.1
Be Technologies, Inc.1
Biodan Medical Systems, Ltd.1
Dantec Medical, Inc.1
Diagnostic Ultrasound Corp.1
Eutectic Electronics, Inc.1
Fiberoptic Sensor Technlogies, Inc.1
Laborie Medical Tech Corp.1
Life-Tech Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order