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

Hook, Microsurgical Ear

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

JYL is the FDA product code for Hook, Microsurgical Ear, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JYL
Device name
Hook, Microsurgical 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
5
Ingested recalls
0

Clearances, product code JYL

By decision year
5 clearances under product code JYL with a decision year between 1978 and 1984, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JYL by decision year
YearClearances
19782
19822
19841

Applicants with the most clearances

Product code JYL
Applicants holding the most 510(k) clearances under product code JYL
ApplicantClearances
Edward Weck, Inc.2
Kelleher Corp.2
Imm Enterprises, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 83 companies shown, in name order