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

Tube, Shunt, Endolymphatic With Valve

21 CFR 874.3850 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KLZ is the FDA product code for Tube, Shunt, Endolymphatic With Valve, a class II device type, regulated under 21 CFR 874.3850. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KLZ
Device name
Tube, Shunt, Endolymphatic With Valve
Regulation
21 CFR 874.3850
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code KLZ

By decision year
1 clearance under product code KLZ with a decision year between 1999 and 1999, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KLZ by decision year
YearClearances
19991

Applicants with the most clearances

Product code KLZ
Applicants holding the most 510(k) clearances under product code KLZ
ApplicantClearances
A.Stein - Regulatory Affairs Consulting1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KLZ.