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

Collector, Urine, (And Accessories) For Indwelling Catheter

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

KNX is the FDA product code for Collector, Urine, (And Accessories) For Indwelling Catheter, a class II device type, regulated under 21 CFR 876.5250. As of , FDA records hold 206 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
KNX
Device name
Collector, Urine, (And Accessories) 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
206
Ingested recalls
21

Clearances, product code KNX

By decision year
206 clearances under product code KNX with a decision year between 1976 and 2011, 1984 the highest year at 28.
Show the numbers
510(k) clearances under FDA product code KNX by decision year
YearClearances
19764
197712
19787
197913
198023
19819
198219
198316
198428
198518
198612
19878
19884
19895
19905
19913
19921
19933
19945
19951
19962
19976
19981
20111

Applicants with the most clearances

Product code KNX
Applicants holding the most 510(k) clearances under product code KNX
ApplicantClearances
Bio D Corp.9
MEDLINE INDUSTRIES, LP - Northfield9
Conphar, Inc.6
The Kendal Co.6
Concord Laboratories, Inc.5
Convatec, A Division of E.R. Squibb & Sons5
Travenol Laboratories, S.A.5
Advanced Clinical Products, Inc.4
Hollister, Inc.4
Manfred Sauer Corp.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 114 companies shown, in name order