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

Instrument, Surgical, Disposable

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

KDC is the FDA product code for Instrument, Surgical, Disposable, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 67 510(k) clearances under this code, the most recent dated , and 38 recalls.

Classification record

Product code
KDC
Device name
Instrument, Surgical, Disposable
Regulation
21 CFR 878.4800
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
67
Ingested recalls
38

Clearances, product code KDC

By decision year
67 clearances under product code KDC with a decision year between 1976 and 1994, 1981 the highest year at 16.
Show the numbers
510(k) clearances under FDA product code KDC by decision year
YearClearances
19761
19772
19782
19791
19805
198116
19825
198312
19843
19851
19867
19903
19913
19924
19942

Applicants with the most clearances

Product code KDC
Applicants holding the most 510(k) clearances under product code KDC
ApplicantClearances
Euro-Med Intl.7
Instranetics, Inc.5
Medcare Products4
Omega-Med Intl., Inc.4
Devon Industries, Inc.3
Axiom Medical, Inc.2
G.D. Searle and Co.2
Ormed Mfg., Inc.2
3M Health Care, Sarns1
Abbott Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 202 companies shown, in name order