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

Mallet

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

HXL is the FDA product code for Mallet, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HXL
Device name
Mallet
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
3
Ingested recalls
1

Clearances, product code HXL

By decision year
3 clearances under product code HXL with a decision year between 1987 and 1988, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HXL by decision year
YearClearances
19872
19881

Applicants with the most clearances

Product code HXL
Applicants holding the most 510(k) clearances under product code HXL
ApplicantClearances
Military Engineering, Inc.1
New England Surgical Instrument Corp.1
Treace Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 190 companies shown, in name order