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

Spoon, Ear

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

JZE is the FDA product code for Spoon, Ear, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
JZE
Device name
Spoon, Ear
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code JZE

By decision year
1 clearance under product code JZE with a decision year between 1989 and 1989, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JZE by decision year
YearClearances
19891

Applicants with the most clearances

Product code JZE
Applicants holding the most 510(k) clearances under product code JZE
ApplicantClearances
Mizuho Orthopedic Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order