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

Perforator, Ear-Lobe

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

JYS is the FDA product code for Perforator, Ear-Lobe, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JYS
Device name
Perforator, Ear-Lobe
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
3
Ingested recalls
0

Clearances, product code JYS

By decision year
3 clearances under product code JYS with a decision year between 1978 and 1986, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JYS by decision year
YearClearances
19781
19862

Applicants with the most clearances

Product code JYS
Applicants holding the most 510(k) clearances under product code JYS
ApplicantClearances
Jay Kenny Templeton1
Onyx Industries, Inc.1
Robert C. Cameron1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order