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

Declotting Tray, Kit (Including Contents)

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FJZ is the FDA product code for Declotting Tray, Kit (Including Contents), a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FJZ
Device name
Declotting Tray, Kit (Including Contents)
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code FJZ

By decision year
3 clearances under product code FJZ with a decision year between 1977 and 1982, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FJZ by decision year
YearClearances
19771
19822

Applicants with the most clearances

Product code FJZ
Applicants holding the most 510(k) clearances under product code FJZ
ApplicantClearances
Dravon Medical, Inc.1
Megaplast, Inc.1
Phoenix Glove Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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