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

Board, Arm (With Cover), Sterile

21 CFR 878.3910 / General, Plastic Surgery
FDA source (opens on fda.gov)

BTX is the FDA product code for Board, Arm (With Cover), Sterile, a class I device type, regulated under 21 CFR 878.3910. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BTX
Device name
Board, Arm (With Cover), Sterile
Regulation
21 CFR 878.3910
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
13
Ingested recalls
0

Clearances, product code BTX

By decision year
13 clearances under product code BTX with a decision year between 1977 and 1994, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BTX by decision year
YearClearances
19771
19781
19791
19811
19821
19832
19871
19883
19901
19941

Applicants with the most clearances

Product code BTX
Applicants holding the most 510(k) clearances under product code BTX
ApplicantClearances
Edgewater Medical Systems, Inc.2
Anago, Inc.1
Datamed, Inc.1
Fibre Formations, Inc.1
Harvey A. Turner, M.D.1
Infection Control Products, Inc.1
Karlin Technology, Inc.1
Medical Innovations, Inc.1
Precept, Inc.1
Rick Robbin & Frederick Auerbach1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order