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KYG — Device, Irrigation, Ocular Surgery Class I

FDA Device Classification

Classification Details

Product Code
KYG
Device Class
Class I
Regulation Number
886.4360
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K010353med-logicsMED-LOGICS DISPOSABLE ALK TUBINGApril 27, 2001
K003036retinalabs.comTURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102December 22, 2000
K993591blade worksBLADEWORKS DISPOSABLE ALK TUBINGDecember 28, 1999
K981116allerganSOVEREIGN CATARACT EXTRACTION SYSTEMMay 19, 1998
K980647eye-deal ocular safety productsEYE IRRIGATOR MODEL #2020May 15, 1998
K974561american medical devicesMOISTAIR FLUID AIR TUBING SETFebruary 19, 1998
K971173med-logicsML DISPOSABLE ALK TUBINGMay 22, 1997
K970161hedges cwpHEDGES CORNEAL WETTING PAKMarch 25, 1997
K954842dutch ophthalmic usaD.O.R.C. VFI/VFE SYSTEMApril 15, 1996
K945171boston surgical productsDISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECEFebruary 8, 1995
K940392peregrine surgicalPEREGRINE PIC MINIPULATORAugust 23, 1994
K935226optical micro systemsI/V POLEFebruary 16, 1994
K935003optical micro systemsELECTRIC I/V POLE OR EIVP2January 25, 1994
K925921site microsurgical systemsMODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTEDecember 6, 1993
K924999escalon trek medicalAUTOPOLE REGULATOR SYSTEMDecember 24, 1992
K924052infinity surgical technologyINFINITY MICRO IRRIGATORDecember 23, 1992
K922996chiron visionMODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICSJuly 27, 1992
K922180o.r. specialtiesLEWICKY O.R.S. TUBINGJuly 2, 1992
K915808visitecAQUEOUS PARACENTESIS PIPETMarch 19, 1992
K914587grieshaber andGRIESHABER AIR/FLUID TUBING SETJanuary 23, 1992