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

Device, Incontinence, Mechanical/Hydraulic

21 CFR 876.5280 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EZY is the FDA product code for Device, Incontinence, Mechanical/Hydraulic, a class III device type, regulated under 21 CFR 876.5280. FDA's definition for this code reads: "PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))". As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
EZY
Device name
Device, Incontinence, Mechanical/Hydraulic
FDA definition
PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))
Regulation
21 CFR 876.5280
Device class
Class III
Review panel
Gastroenterology, Urology
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
7

Companies listing this code with FDA

Companies whose registered establishments list this code