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
K972383Substantially Equivalent

Easy-Jet Device

A.Stein - Regulatory Affairs Consulting, Ginot Shomron 44853, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972383 is the FDA 510(k) clearance record for EASY-JET DEVICE, a class II device, cleared for A.Stein - Regulatory Affairs Consulting on under FDA product code KLZ (Tube, Shunt, Endolymphatic With Valve). FDA records list 5 510(k) clearances for A.Stein - Regulatory Affairs Consulting, from to . As of , FDA records show no recalls naming K972383.

Clearance record

Decision date
Received
(880 days to decision)
Product code
KLZ Tube, Shunt, Endolymphatic With Valve
Regulation
21 CFR 874.3850
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
A.Stein - Regulatory Affairs Consulting P.o.b. 454, Ginot Shomron 44853, IL
510(k) summary
Statement
Third party review
No

Clearances, product code KLZ

Trailing 12 months

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

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