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

Retractor, Ent

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

KAL is the FDA product code for Retractor, Ent, 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 one recall.

Classification record

Product code
KAL
Device name
Retractor, Ent
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
1

Clearances, product code KAL

By decision year
5 clearances under product code KAL with a decision year between 1977 and 1987, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KAL by decision year
YearClearances
19771
19782
19841
19871

Applicants with the most clearances

Product code KAL
Applicants holding the most 510(k) clearances under product code KAL
ApplicantClearances
Edward Weck, Inc.2
Microtek Medical LLC1
Treace Medical, Inc.1
V. Mueller O.V. Baxter Healthcare Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 117 companies shown, in name order