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HOZ — Sponge, Ophthalmic Class II

FDA Device Classification

Classification Details

Product Code
HOZ
Device Class
Class II
Regulation Number
886.4790
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K132796huizhou foryou medical devices coSUNTOUCH EYE SPEAROctober 30, 2013
K130117network medical productsNETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSOctober 29, 2013
K091240alphamedALPHAMED SURGICAL SPEAR, MODEL 70-5000October 23, 2009
K082460longtek scientific coCENEFOM PVA SURGICAL SPEARDecember 15, 2008
K012196ultracell medical technologiesULTRACELL ABSORBENT STICKAugust 24, 2001
K011191medtronic xomedMEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESJune 26, 2001
K003842prescottPRESCOTT'S SURGICAL SPEARApril 13, 2001
K002279med-logicsML EYE SPEAR, MODEL ML 27 ESAugust 18, 2000
K993883m-pactM-PACT CORNEAL LIGHT SHIELDDecember 21, 1999
K990671hurricane medicalDRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPMay 10, 1999
K990749x-tech medicalSOF-SUCTION FLUID EVACUATION SYSTEMApril 2, 1999
K982599ophthalmic solutionsTHE FREMSTAD RINGFebruary 16, 1999
K974313hydroferaHYDROFERA SURGICAL SPEARMarch 2, 1998
K972633ultracell medical technologiesULTRACELL SUCTION SPONGEDecember 17, 1997
K972693deroyal industriesDEROYAL INDUSTRIES, INC. SURGICAL EYE SPEARSeptember 30, 1997
K971832m-pact worldwide managementIVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALJuly 31, 1997
K964855shippert medical technologiesEXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELDMarch 4, 1997
K946016ivalonIVALON OPHTHALMIC SPONGEMarch 22, 1995
K950241oasis medicalOPHTHALMIC SPONGESFebruary 27, 1995
K942642surgin surgical instrumentationSURGI-WIPEJuly 15, 1994