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

Block, Cutting, Ent, Sterile

21 CFR 874.3540 / Ear, Nose, Throat
FDA source (opens on fda.gov)

JXS is the FDA product code for Block, Cutting, Ent, Sterile, a class I device type, regulated under 21 CFR 874.3540. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JXS
Device name
Block, Cutting, Ent, Sterile
Regulation
21 CFR 874.3540
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
0

Clearances, product code JXS

By decision year
2 clearances under product code JXS with a decision year between 1982 and 1995, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JXS by decision year
YearClearances
19821
19951

Applicants with the most clearances

Product code JXS
Applicants holding the most 510(k) clearances under product code JXS
ApplicantClearances
Solarcare Technologies Corp,Inc.1
Treace Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order