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
JYKClass I

Holder, Ear Speculum

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

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

Classification record

Product code
JYK
Device name
Holder, Ear Speculum
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
1
Ingested recalls
0

Clearances, product code JYK

By decision year
1 clearance under product code JYK with a decision year between 1982 and 1982, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JYK by decision year
YearClearances
19821

Applicants with the most clearances

Product code JYK
Applicants holding the most 510(k) clearances under product code JYK
ApplicantClearances
Kelleher Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order