ClearanceBrief
Panels › Obstetrics/Gynecology › Product code HIG · Class 2

Insufflator, Hysteroscopic

Regulation 884.1700

2510(k)s in 12 months (57 all time)
1recalls in 12 months (6 all time)
5recalls that name a 510(k)
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Top companies in HIG

Company510(k)sRecalls
W.O.M. World of Medicine AG100
Davol Inc., Sub. C. R. Bard, Inc.50
KARL STORZ Endoscopy-America, Inc.41
Thermedx, LLC41
Cabot Medical Corp.30
KARL STORZ SE & CO. KG30
WOM World Of Medicine AG03
F.M. Wiest USA, Inc.20
Hologic, Inc.20
Ackrad Laboratories10
Decided510(k)Device and applicantCode
Dec 14, 1989K895907HYSTEROFLATOR 2001
Cabot Medical Corp.
HIG
Jun 16, 1989K892001DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
Dexide, Inc.
HIG
Mar 17, 1989K891028UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
Zinnanti Surgical Instruments, Inc.
HIG
Jul 15, 1988K881680ACKRAD H/S PROCEDURE TRAY
Ackrad Laboratories
HIG
Feb 26, 1988K873527DECHERNEY HYSTEROSCOPY PUMP SYSTEM
Cabot Medical Corp.
HIG
Nov 16, 1987K872860INSUFFLATOR TUBING
Medline Industries, Inc.
HIG
Sep 21, 1984K842943AXCAN UTERINE SUCCION INJECTOR
Axcan Scientific Corp.
HIG

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