510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K935584Substantially Equivalent

Mednext Bur

Mednext, Inc., West Point Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935584 is the FDA 510(k) clearance record for MEDNEXT BUR, a class I device, cleared for Mednext, Inc. on under FDA product code EQJ (Bur, Ear, Nose And Throat). FDA records list 7 510(k) clearances for Mednext, Inc., from to . As of , FDA records show no recalls naming K935584.

Clearance record

Decision date
Received
(96 days to decision)
Product code
EQJ Bur, Ear, Nose And Throat
Regulation
21 CFR 874.4140
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Mednext, Inc. 3878 Prospect Ave., Suite 24, West Point Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code EQJ

Trailing 12 months

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

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