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

Prosthesis, Breast, External, Used With Adhesive

21 CFR 878.3800 / General, Plastic Surgery
FDA source (opens on fda.gov)

KCZ is the FDA product code for Prosthesis, Breast, External, Used With Adhesive, a class I device type, regulated under 21 CFR 878.3800. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KCZ
Device name
Prosthesis, Breast, External, Used With Adhesive
Regulation
21 CFR 878.3800
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
13
Ingested recalls
1

Clearances, product code KCZ

By decision year
13 clearances under product code KCZ with a decision year between 1989 and 1999, 1990 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KCZ by decision year
YearClearances
19891
19903
19911
19922
19933
19941
19951
19991

Applicants with the most clearances

Product code KCZ
Applicants holding the most 510(k) clearances under product code KCZ
ApplicantClearances
MEDLINE INDUSTRIES, LP - Northfield5
Almost U., Inc.1
Dekumed, Kunststofftechnik Degler GmbH1
Great Bay Medical Products, Inc.1
Hemispheres Marketing Co., Ltd.1
Jobst Institute, Inc.1
Maxol Limited L.C.1
Spenco Medical Corp.1
Straumann USA, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order