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
49–57 of 57
Cleared Mar 05, 1990
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
K894259
Washington Regulatory Services
Obstetrics & Gynecology · 258d
Cleared Dec 19, 1989
HUI MINI-FLEX
K895659
Unimar, Inc.
Obstetrics & Gynecology · 90d
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
Cleared Sep 21, 1984
AXCAN UTERINE SUCCION INJECTOR
K842943
Axcan Scientific Corp.
Obstetrics & Gynecology · 58d