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HMX — Cannula, Ophthalmic Class I

FDA Device Classification

Classification Details

Product Code
HMX
Device Class
Class I
Regulation Number
886.4350
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K010305micron surgicalWEISS RETINAL CANNULAMay 2, 2001
K000457retinalabs.comVERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMMay 9, 2000
K970873american medical devicesENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)May 20, 1997
K943932pharma-plastSTERISEAL OPHTHALMIC CANNULAJanuary 18, 1995
K942403microsurgical technologyINFUSION CANNULAAugust 17, 1994
K934844microsurgical technologyINTER TIP TApril 19, 1994
K930113kirwan surgical productsKIRWAN IRRIGATION/ASPIRATION HANDPIECEFebruary 17, 1994
K921488surgical technologiesASPIRATING ENDO OCULAR PROBE W/ILLUMINATIONMay 7, 1992
K915074biomedical dynamicsIRRIGATOR/ASPIRATOR PROBEFebruary 5, 1992
K904074visitecVITREORETINAL INFUSION CANNULAFebruary 26, 1991
K901618tamcenanOCULAR INFUSION CANNULA SYSTEMMay 31, 1990
K890782grieshaber andGRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)June 23, 1989
K882884storz instrumentSTORZ INFUSION CANNULAAugust 4, 1988
K880347myocureANESTHESIA/RETROBULBAR NEEDLESMay 3, 1988
K880346myocureCANNULASMay 3, 1988
K875030rudolph beaverOCU-1May 3, 1988
K881487surgical instrumentOPHTHALMIC CANNULAApril 29, 1988
K874971advanced surgical productsPRISMA DISPOSABLE PEARCE IRRIGATING VECTUSApril 13, 1988
K874992advanced surgical productsPRISMA DISPOSABLE IRRIGATING LENS DIALERApril 13, 1988
K874972advanced surgical productsPRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULAApril 13, 1988