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

Nasal Spray, Ent Delivery

21 CFR 874.5220 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KCO is the FDA product code for Nasal Spray, Ent Delivery, a class I device type, regulated under 21 CFR 874.5220. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
KCO
Device name
Nasal Spray, Ent Delivery
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code KCO

By decision year
1 clearance under product code KCO with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KCO by decision year
YearClearances
19771

Applicants with the most clearances

Product code KCO
Applicants holding the most 510(k) clearances under product code KCO
ApplicantClearances
Mcdonald and Assoc., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order