HIG · Class II · 21 CFR 884.1700

FDA Product Code HIG: Insufflator, Hysteroscopic

Leading manufacturers include W.O.M. World of Medicine GmbH, Davol Inc., Sub. C. R. Bard, Inc. and KARL STORZ Endoscopy-America, Inc..

57
Total
57
Cleared
245d
Avg days
1984
Since
57 devices
25–48 of 57
Cleared Dec 11, 1997
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
K970078
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 336d
Cleared Sep 05, 1997
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR
K971492
Bei Medical Systems Co., Inc.
Obstetrics & Gynecology · 134d
Cleared Jan 10, 1997
HYSTERO CO2-PNEU 2221
K964136
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 87d
Cleared Oct 03, 1996
KARL STORZ MODEL 203020 20 EQUIMAT
K961091
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 198d
Cleared Oct 20, 1995
HYS-SURGIMAT
K934866
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 738d
Cleared Aug 15, 1995
HYS-SURGIFLATOR VP
K933847
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 739d
Cleared May 25, 1995
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K950961
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 84d
Cleared Apr 19, 1995
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
K941743
Cabot Medical Corp.
Obstetrics & Gynecology · 377d
Cleared Apr 11, 1995
HYS-SURGIFLATOR
K924523
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 945d
Cleared Jan 24, 1995
THE KARL STORZ HAMOU ENDOMAT
K936231
Karl Storz Endoscopy
Obstetrics & Gynecology · 391d
Cleared Dec 30, 1994
BARD HYSTERO-FLO II PUMP
K933384
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 536d
Cleared Dec 29, 1994
CONCEPT UNIVERSAL PUMP SYSTEM
K933873
Linvatec Corp.
Obstetrics & Gynecology · 507d
Cleared Dec 15, 1994
HYSTEROMAT(TM) 3700
K921871
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 969d
Cleared Oct 17, 1994
HYSTEROMED 100
K930912
Northgate Technologies, Inc.
Obstetrics & Gynecology · 602d
Cleared Mar 25, 1994
WOM HYSTEROFLATOR OP
K922632
W.O.M. GmbH
Obstetrics & Gynecology · 751d
Cleared Jan 24, 1994
7-510-25 HYSTEROMED TUBING KIT
K931606
Nortech
Obstetrics & Gynecology · 298d
Cleared Sep 24, 1993
INSUFFLATOR TUBING KIT
K922197
O.R. Concepts, Inc.
Obstetrics & Gynecology · 501d
Cleared Dec 18, 1991
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K912498
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 196d
Cleared Nov 21, 1991
HYSTEROFLATOR 1500
K911844
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 210d
Cleared Sep 20, 1991
LM-100/200LOW FLOW INSUFFLATOR
K912789
Leisegang Medical, Inc.
Obstetrics & Gynecology · 87d
Cleared Apr 29, 1991
HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
K905495
Frigitronics, Inc.
Obstetrics & Gynecology · 143d
Cleared Feb 28, 1991
GYN-1500 HYSTEROSCOPIC INUFFLATOR
K905706
Circon Acmi
Obstetrics & Gynecology · 66d
Cleared Oct 10, 1990
DAVOL SCOPE IRRIGATION SYSTEM
K901288
C.R. Bard, Inc.
Obstetrics & Gynecology · 204d
Cleared May 21, 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908
Zimmer, Inc.
Obstetrics & Gynecology · 83d