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GYK — Instrument, Shunt System Implantation Class I

FDA Device Classification

Classification Details

Product Code
GYK
Device Class
Class I
Regulation Number
882.4545
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K962761cookREIGEL TUNNELING DEVICEOctober 11, 1996
K934391radionicsV/P AND L/P CATHETER PASSERSNovember 19, 1993
K930606pudenz-schulte medical researchPS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERSeptember 10, 1993
K932273cordisCORDIS TUNNELERAugust 23, 1993
K895868baxter healthcareHEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEOctober 31, 1989
K883607codman and shurtleffPEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERSeptember 30, 1988
K873771american v. muellerHEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRODecember 18, 1987
K865075holter-hausner intlH-H SUBGALEAL TROCARJanuary 13, 1987
K853370holter-hausner intlH-H CATHETER PASSERS(TACL DESIGNSeptember 18, 1985
K853368holter-hausner intlH-H SHUNT INTRODUCERSeptember 6, 1985
K841553holter-hausner intlH-H SHUNT PASSERSMay 14, 1984
K792639holter-hausner intlH-H SHUNT INTRODUCERDecember 31, 1979
K771529cordisPERITONEAL INTRODUCER & SHEATHAugust 16, 1977