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

Beads, Hydrophilic, For Wound Exudate Absorption

21 CFR 878.4018 / General, Plastic Surgery
FDA source (opens on fda.gov)

KOZ is the FDA product code for Beads, Hydrophilic, For Wound Exudate Absorption, a class I device type, regulated under 21 CFR 878.4018. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KOZ
Device name
Beads, Hydrophilic, For Wound Exudate Absorption
Regulation
21 CFR 878.4018
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
22
Ingested recalls
0

Clearances, product code KOZ

By decision year
22 clearances under product code KOZ with a decision year between 1976 and 1991, 1987 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KOZ by decision year
YearClearances
19761
19781
19801
19821
19841
19851
19874
19882
19892
19904
19914

Applicants with the most clearances

Product code KOZ
Applicants holding the most 510(k) clearances under product code KOZ
ApplicantClearances
Smith & Nephew United, Inc.3
Hollister, Inc.2
Marion Laboratories, Inc.2
Perstorp AB C/O Robert Joel Slomoff2
Pharmaseal Laboratories2
American Pharmaseal Div. Ahsc1
Beiersdorf, Inc.1
Bipore, Inc.1
MEDLINE INDUSTRIES, LP - Northfield1
Controlled Therapeutics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order