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

Urinary Drainage Collection Kit, For Indwelling Catheter

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

FCN is the FDA product code for Urinary Drainage Collection Kit, For Indwelling Catheter, a class II device type, regulated under 21 CFR 876.5250. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
FCN
Device name
Urinary Drainage Collection Kit, For Indwelling Catheter
Regulation
21 CFR 876.5250
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
10
Ingested recalls
3

Clearances, product code FCN

By decision year
10 clearances under product code FCN with a decision year between 1977 and 1995, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FCN by decision year
YearClearances
19772
19781
19882
19891
19921
19941
19952

Applicants with the most clearances

Product code FCN
Applicants holding the most 510(k) clearances under product code FCN
ApplicantClearances
Medical Inventors Corp., Inc.2
Catco Medical, Inc.1
Kendall Research Center1
Knight Medical, Inc.1
Lake Medical Products, Inc.1
Medical Devices Inc.1
Mentor1
Terumo America, Inc.1
Trinity Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order