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

Tracheotome

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

LJW is the FDA product code for Tracheotome, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LJW
Device name
Tracheotome
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
2
Ingested recalls
1

Clearances, product code LJW

By decision year
2 clearances under product code LJW with a decision year between 1983 and 1994, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LJW by decision year
YearClearances
19831
19941

Applicants with the most clearances

Product code LJW
Applicants holding the most 510(k) clearances under product code LJW
ApplicantClearances
Kelleher Corp.1
Wrightmedicaltechnologyinc1

Companies listing this code with FDA

Companies whose registered establishments list this code