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

Apparatus, Suturing, Stomach And Intestinal

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

FHM is the FDA product code for Apparatus, Suturing, Stomach And Intestinal, 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 no recalls.

Classification record

Product code
FHM
Device name
Apparatus, Suturing, Stomach And Intestinal
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
0

Clearances, product code FHM

By decision year
2 clearances under product code FHM with a decision year between 1980 and 1980, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FHM by decision year
YearClearances
19802

Applicants with the most clearances

Product code FHM
Applicants holding the most 510(k) clearances under product code FHM
ApplicantClearances
United States Surgical, A Division of Tyco Healthc2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order