KOH — Instrument, Manual, General Obstetric-Gynecologic Class I

FDA Device Classification

Classification Details

Product Code
KOH
Device Class
Class I
Regulation Number
884.4520
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K000212karl storz endoscopy-americaKSEA CHARDONNES MORCELLATION KNIFEApril 21, 2000
K921730medikmarkC-SECTION PACKJune 15, 1994
K921732medikmarkMINOR LAP SETJune 15, 1994
K891351simpson/basyeNEWPORT LATERAL VAGINAL RETRACTORMay 11, 1989
K892693zinnanti surgical instrumentsVAGINAL SPECULA: CUSCO, GUTTMAN, INFANTMay 11, 1989
K891035zinnanti surgical instrumentsNEEDLE EXTENSIONSMarch 22, 1989
K891049zinnanti surgical instrumentsZEPPELIN SCISSORSMarch 17, 1989
K863610ob/gyn conceptsTHE OB-GYN CONCEPTS VAGINAL ASPIRATORJanuary 7, 1987
K840308imm enterprisesCAT. 4-OBSTETRICS GYNECOLOGY DEV'SMarch 5, 1984
K823792american v. muellerQUARTZ RETRACTOR/PROBEJanuary 18, 1983
K812204reznik instrumentsUTERINE MANIPULATORSOctober 13, 1981
K800834v.s.s.iSER-TEXJune 30, 1980
K790851c. intlVAGI-PRESS #401July 30, 1979
K781767c.r. bardINSTRUMENT CURNETT MINI-CONER BIOPSYDecember 7, 1978
K780460m. joel gebhart, d.d.sDENTAL AIR BRUSHJune 28, 1978