510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FZOClass I

Chisel, Surgical, Manual

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

FZO is the FDA product code for Chisel, Surgical, Manual, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FZO
Device name
Chisel, Surgical, Manual
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
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 FZO

By decision year
2 clearances under product code FZO with a decision year between 1984 and 1985, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FZO by decision year
YearClearances
19841
19851

Applicants with the most clearances

Product code FZO
Applicants holding the most 510(k) clearances under product code FZO
ApplicantClearances
Artiberia1
Imm Enterprises, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 228 companies shown, in name order