510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
JYMClass I

Inserter, Myringotomy Tube

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

JYM is the FDA product code for Inserter, Myringotomy Tube, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JYM
Device name
Inserter, Myringotomy Tube
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
4
Ingested recalls
0

Clearances, product code JYM

By decision year
4 clearances under product code JYM with a decision year between 1982 and 1993, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JYM by decision year
YearClearances
19822
19871
19931

Applicants with the most clearances

Product code JYM
Applicants holding the most 510(k) clearances under product code JYM
ApplicantClearances
Treace Medical, Inc.2
Exmoor Plastics Limited1
Sur-Med Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order