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EQJ — Bur, Ear, Nose And Throat Class I

FDA Device Classification

Classification Details

Product Code
EQJ
Device Class
Class I
Regulation Number
874.4140
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K161514stryker corporationPrecision Thin Reciprocating Blade, 0.010in.January 17, 2017
K041985medtronic xomedXPS CURVED BURAugust 12, 2004
K974232gyrus entESSENTIAL SHAVER SYSTEMJanuary 12, 1998
K960853xomedACE SYSTEMApril 3, 1996
K955704trebay medicalTREBAY MICRODEBRIDER SYSTEMJanuary 30, 1996
K955294trebay medicalSOF - ABRASION BURDecember 22, 1995
K954912trebay medicalTREBAY IRRIGATED CUTTER BLADE (MODIFICATION)December 6, 1995
K953370karl storz endoscopy-americaKARL STORZ ENT SHAVERSeptember 6, 1995
K950337karl storz endoscopy-americaKARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILLAugust 23, 1995
K952609trebay medicalREDI DRILL DRILL SYSTEMJuly 31, 1995
K953096smith and nephew richardsESSENTIAL SHAVER SYSTEMJuly 28, 1995
K946332karl storz endoscopy-americaKARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATIONJune 5, 1995
K951526trebay medicalTREBAY IRRGATED CUTTER BLADEMay 12, 1995
K935584mednextMEDNEXT BURFebruary 22, 1994
K895738micromedicsMICROMEDICS EAR, NOSE AND THROAT BURSDecember 19, 1989
K893499cmsiCMS FAST CUT, CMS DIAMOND AND CMS WIRE PASSNovember 16, 1989
K802503spire medicalMICRO-SUGICAL POWER INSTRUMENT SYSTEMOctober 31, 1980
K792028american sterilizerOTOTOME BUROctober 26, 1979