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HES — Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) Class II

FDA Device Classification

Classification Details

Product Code
HES
Device Class
Class II
Regulation Number
884.1300
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140761carefusion 2200KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULAApril 21, 2014
K000340rocket medicalHYSTALOG HSG CATHETERApril 19, 2000
K903209adler instrumentMAXI-FLOW INSUFFLATOR TUBING SET W/FILTERDecember 21, 1990
K903208adler instrumentMAXI-FLOW INSUFFLATOR TUBING SETDecember 17, 1990
K904473unimarKRONNER MANIPUJECTORDecember 14, 1990
K901413core dynamicsCORE DISPOSABLE INSUFFLATION TUBINGSeptember 24, 1990
K891290cook ob/gynSHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETERMay 23, 1989
K890869c.r. bardBARD HYSTEROSALPINGOGRAPHY CATHETERSApril 25, 1989
K875137f.m. wiest usaLAPAROFLATOR 3000, STANDARD AND ELECTRONICMarch 2, 1988
K873515zinnanti surgical instrumentsUTERINE INJECTOR 2MMSeptember 29, 1987
K862310cabot medicalCABOT MEDICAL VARIABLE FLOW INSUFFLATORAugust 12, 1986
K844173bionexusFEMTESTAugust 14, 1985
K841682humiUTERINE INJECTOR 4.0MMJuly 3, 1984