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

Accessories, Catheter, G-U

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

KNY is the FDA product code for Accessories, Catheter, G-U, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KNY
Device name
Accessories, Catheter, G-U
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
65
Ingested recalls
3

Clearances, product code KNY

By decision year
65 clearances under product code KNY with a decision year between 1976 and 2026, 1993 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code KNY by decision year
YearClearances
19761
19771
19781
19821
19831
19871
19882
19892
19903
19914
19922
19937
19946
19954
19962
19971
19983
19991
20001
20032
20042
20053
20063
20091
20111
20121
20132
20143
20171
20181
20261

Applicants with the most clearances

Product code KNY
Applicants holding the most 510(k) clearances under product code KNY
ApplicantClearances
Lake Region Mfg., Inc.3
Percutaneous Systems, Inc.3
Promepla S.A.M3
Solace Therapeutics3
Avail Medical Products, Inc.2
Boston Scientific Corporation2
Convatec, A Division of E.R. Squibb & Sons2
Kit Pak, Inc.2
Medical Device Technologies, Inc.2
Orion Life Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order