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

Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile

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

NNY is the FDA product code for Sheath, Corrugated Rubber, For Non-Indwelling Catheter, 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 EYT". As of , FDA records hold no 510(k) clearances under this code and 3 recalls.

Classification record

Product code
NNY
Device name
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile
FDA definition
Urine collector and accessories; see product code EYT.
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
3

Companies listing this code with FDA

Companies whose registered establishments list this code