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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
K874987advanced surgical productsPRISMA DISPOSABLE DOUBLE I/A CANNULAApril 13, 1988
K874973advanced surgical productsPRISMA DISPOSABLE SIMCOE I/A CANNULAApril 13, 1988
K874998advanced surgical productsPRISMA DISPOSABLE U-SHAPED CANNULAApril 13, 1988