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

Holder, Speculum, Ent

21 CFR 878.1800 / General, Plastic Surgery
FDA source (opens on fda.gov)

KAG is the FDA product code for Holder, Speculum, Ent, a class I device type, regulated under 21 CFR 878.1800. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KAG
Device name
Holder, Speculum, Ent
Regulation
21 CFR 878.1800
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
2
Ingested recalls
0

Clearances, product code KAG

By decision year
2 clearances under product code KAG with a decision year between 1983 and 1984, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KAG by decision year
YearClearances
19831
19841

Applicants with the most clearances

Product code KAG
Applicants holding the most 510(k) clearances under product code KAG
ApplicantClearances
Cardiac Pacemakers, Inc.1
E K Ind., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order