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

Irrigator, Sinus

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KAR is the FDA product code for Irrigator, Sinus, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KAR
Device name
Irrigator, Sinus
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code KAR

By decision year
3 clearances under product code KAR with a decision year between 1986 and 2013, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KAR by decision year
YearClearances
19861
19931
20131

Applicants with the most clearances

Product code KAR
Applicants holding the most 510(k) clearances under product code KAR
ApplicantClearances
Gm Engineering, Inc.1
Hedgepath, LLC1
JEDMED Instrument Company1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 72 companies shown, in name order