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

Binder, Abdominal

21 CFR 880.5160 / General Hospital
FDA source (opens on fda.gov)

FSD is the FDA product code for Binder, Abdominal, a class I device type, regulated under 21 CFR 880.5160. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FSD
Device name
Binder, Abdominal
Regulation
21 CFR 880.5160
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code FSD

By decision year
5 clearances under product code FSD with a decision year between 1976 and 1989, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FSD by decision year
YearClearances
19761
19771
19811
19831
19891

Applicants with the most clearances

Product code FSD
Applicants holding the most 510(k) clearances under product code FSD
ApplicantClearances
Fidelty Hearing Instruments, Inc.1
Kuhn Industries1
Oticon, Inc.1
R.G. Moore1
Tecnol New Jersey Wound Care, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 103 companies shown, in name order