HKP — Instrument, Vitreous Aspiration And Cutting, Battery-Powered Class II

FDA Device Classification

Classification Details

Product Code
HKP
Device Class
Class II
Regulation Number
886.4150
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K952558aaron medical industriesAARON VAC 2March 19, 1997
K950056grieshaber andTHE GRIESHABER AXIAL CUTTERMay 5, 1995
K950287medical instrument development laboratoriesUNIVIT PROBEApril 10, 1995
K896622visitecVISITEC VITRECTOMY UNITApril 4, 1990
K890595mentor o and oMENTOR ANTERIOR SEGMENT VITRECTORApril 17, 1989
K832074coopervisionCAVITRON/KELMAN PHACO-EMULSIFIER ASPIRAAugust 1, 1983
K822599frigitronics of connecticutKEATES I/A SYSTEM FRIGITRONICS 4000October 6, 1982
K813273optical micro systemsEMERGENCY POWER PAC (EMPAC)December 31, 1981
K810152temporaty surgical systemsX-VEEMarch 17, 1981
K801231coburn optical indEYE-VACJuly 21, 1980
K791898cooper medical devicesOCUTOME MODEL 8000October 30, 1979
K791000conceptVITREOUS SUCTION/CUTTERSeptember 4, 1979
K790893varian assocSTATAugust 28, 1979
K780852varian assocCLINITEX VIS-X ASPIRATING ACCESSORYNovember 3, 1978
K761353conceptVITEROUS SUCTION CUTTERJanuary 5, 1977
K760684varian assocVISC X-VITREOUS ASPIRATING & CUT. INSTROctober 5, 1976