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

Kit, Catheter, Urinary (Exludes Hiv Testing)

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NWO is the FDA product code for Kit, Catheter, Urinary (Exludes Hiv Testing), a class II device type, regulated under 21 CFR 876.5130. FDA's definition for this code reads: "Urinary Catheterization Kit (Excludes HIV Testing)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 3 recalls.

Classification record

Product code
NWO
Device name
Kit, Catheter, Urinary (Exludes Hiv Testing)
FDA definition
Urinary Catheterization Kit (Excludes HIV Testing)
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
3

Clearances, product code NWO

By decision year
1 clearance under product code NWO with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NWO by decision year
YearClearances
20071

Applicants with the most clearances

Product code NWO
Applicants holding the most 510(k) clearances under product code NWO
ApplicantClearances
Colorado Catheter Company, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NWO.