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HNY — Cystotome Class I

FDA Device Classification

Classification Details

Product Code
HNY
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
K961524sterilabSTERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPUMay 16, 1996
K880345myocureCYSTOTOMES/KNIFESMay 3, 1988
K875001advanced surgical productsPRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOMEApril 13, 1988
K874993advanced surgical productsPRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOMEApril 13, 1988
K874976advanced surgical productsPRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOMEApril 13, 1988
K874997advanced surgical productsPRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOMEApril 13, 1988
K874983advanced surgical productsPRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOMEApril 13, 1988
K874975advanced surgical productsPRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOMEApril 13, 1988
K873163van dellenVAN DELLEN IRRIGATING CYSTOTOMESeptember 4, 1987
K871365noetixCAPSULECTOMER CYSTOTOMEApril 16, 1987
K870439lookLOOK IRRIGATING CYSTOTOMESFebruary 20, 1987
K862709rudolph beaverMECHANICAL CYSTITOMEAugust 1, 1986
K852934precision-cosmet coPRECISION - COSMET CAPSULE COUPEURAugust 8, 1985
K841101miami eye technologyCLAYMAN-PAREL CAPSULE COUPEURMay 16, 1984
K840475cilcoCYSTOTOME, 140-SApril 5, 1984
K840660sharpointPOSTERIOR CAPSULOTOMY CYSTITOMEMarch 16, 1984
K840659sharpointANTERIOR CAPSULECTOMY CYSTITOMEMarch 16, 1984
K831916coopervisionDISPOSABLE CYSTOTOMEJuly 12, 1983
K830040contemporary surgical systemsDISPOSABLE CYSTOTOMEFebruary 7, 1983
K790244visitecCYSTOTOMESFebruary 12, 1979