510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863430Substantially Equivalent

Byron Bivalve Nasal Splints

Byron Medical, Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863430 is the FDA 510(k) clearance record for BYRON BIVALVE NASAL SPLINTS, a class II device, cleared for Byron Medical on under FDA product code FZE (Prosthesis, Nose, Internal). FDA records list 27 510(k) clearances for Byron Medical, from to . As of , FDA records show no recalls naming K863430.

Clearance record

Decision date
Received
(13 days to decision)
Product code
FZE Prosthesis, Nose, Internal
Regulation
21 CFR 878.3680
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Byron Medical 3280 E. Hemisphere Loop, Tucson AZ
Third party review
No

Clearances, product code FZE

Trailing 12 months

FDA records hold no clearances under product code FZE in the trailing twelve months.

FDA records show no clearances under product code FZE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260