510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935053Substantially Equivalent

Bivona Nasal Turbinate Stent

Bivona Medical Technologies, Gary IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935053 is the FDA 510(k) clearance record for BIVONA NASAL TURBINATE STENT, a class I device, cleared for Bivona Medical Technologies on under FDA product code LYA (Splint, Intranasal Septal). FDA records list 50 510(k) clearances for Bivona Medical Technologies, from to . As of , FDA records show no recalls naming K935053.

Clearance record

Decision date
Received
(253 days to decision)
Product code
LYA Splint, Intranasal Septal
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Bivona Medical Technologies 5700 W. 23rd Ave., Gary IN
510(k) summary
Summary
Third party review
No

Clearances, product code LYA

Trailing 12 months

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

FDA records show no clearances under product code LYA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYA, 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