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HQX — Implant, Orbital, Extra-Ocular Class II

FDA Device Classification

Classification Details

Product Code
HQX
Device Class
Class II
Regulation Number
886.3340
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K023481microvisionMICROVISION SCLERAL BUCKLING COMPONENTSJanuary 8, 2003
K983581bio-vascularOCU-GUARD AND OCU-GUARD SUPPLENovember 6, 1998
K980816fci ophthalmicsRETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGESSeptember 18, 1998
K963219fci ophthalmicsRETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SOctober 28, 1996
K950806miraSOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSJune 5, 1996
K950599storz ophthalmicsSTORS SCLERAL SPONGE II (LINCOFF DESIGN)March 2, 1995
K945172visitecVISITEC SILICONE RETINAL IMPLANTS/EXPLANTSJanuary 17, 1995
K902308tamcenanTAMCENAN OCULAR EXPLANTS AND BANDSJune 19, 1990
K901002oculo plastikO'DONNELL, SOCKET RECONSTRUCTION PROSTHESESMay 22, 1990
K900929oculo plastikPUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERALMay 18, 1990
K900927oculo plastikCODERE-DURETTE ORBITAL FLOOR IMPLANTMay 15, 1990
K900928oculo plastikCOX MALAR EMINENCE IMPLANTSMay 15, 1990
K900930oculo plastikSPIVEY-ALLEN ORBITAL FLOOR IMPLANTMay 15, 1990
K863946porex medicalPOREX(TM) EXTRA-OCULAR ORBITAL IMPLANTFebruary 27, 1987
K832481storz instrumentSCLERAL BUCKLING IMPLANTS DIF/TYPESSeptember 20, 1983
K800140dow corning corp. healthcare industries materialsSILASTIC SCLERAL SPONGE II W/CIRCLING BDMarch 3, 1980