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

Device, Incontinence, Urosheath Type, Non-Sterile

21 CFR 876.5250 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NNX is the FDA product code for Device, Incontinence, Urosheath Type, Non-Sterile, a class I device type, regulated under 21 CFR 876.5250. FDA's definition for this code reads: "Urine collector and accessories; see product code EXJ". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NNX
Device name
Device, Incontinence, Urosheath Type, Non-Sterile
FDA definition
Urine collector and accessories; see product code EXJ
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order