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 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 Oct 17, 1994
HYSTEROMED 100
K930912
Northgate Technologies, Inc.
Obstetrics & Gynecology · 602d
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 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
Cleared Dec 14, 1989
HYSTEROFLATOR 2001
K895907
Cabot Medical Corp.
Obstetrics & Gynecology · 69d
Cleared Jun 16, 1989
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001
Dexide, Inc.
Obstetrics & Gynecology · 80d
Cleared Mar 17, 1989
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
K891028
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d
Cleared Jul 15, 1988
ACKRAD H/S PROCEDURE TRAY
K881680
Ackrad Laboratories
Obstetrics & Gynecology · 87d
Cleared Feb 26, 1988
DECHERNEY HYSTEROSCOPY PUMP SYSTEM
K873527
Cabot Medical Corp.
Obstetrics & Gynecology · 178d
Cleared Nov 16, 1987
INSUFFLATOR TUBING
K872860
Medline Industries, Inc.
Obstetrics & Gynecology · 118d