HES · Class II · 21 CFR 884.1300

FDA Product Code HES: Insufflator, Carbon-dioxide, Uterotubal (and Accessories)

Leading manufacturers include Rocket Medical Plc, Carefusion 2200, Inc. and Cabot Medical Corp..

13
Total
13
Cleared
102d
Avg days
1984
Since

FDA 510(k) Cleared Insufflator, Carbon-dioxide, Uterotubal (and Accessories) Devices (Product Code HES)

13 devices
1–13 of 13
Cleared Apr 21, 2014
KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA
K140761
Carefusion 2200, Inc.
Obstetrics & Gynecology · 26d
Cleared Apr 19, 2000
HYSTALOG HSG CATHETER
K000340
Rocket Medical Plc
Obstetrics & Gynecology · 76d
Cleared Sep 24, 1990
CORE DISPOSABLE INSUFFLATION TUBING
K901413
Core Dynamics, Inc.
Obstetrics & Gynecology · 182d
Cleared May 23, 1989
SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
K891290
Cook Ob/Gyn
Obstetrics & Gynecology · 74d
Cleared Apr 25, 1989
BARD HYSTEROSALPINGOGRAPHY CATHETERS
K890869
C.R. Bard, Inc.
Obstetrics & Gynecology · 63d
Cleared Sep 29, 1987
UTERINE INJECTOR 2MM
K873515
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 29d
Cleared Aug 12, 1986
CABOT MEDICAL VARIABLE FLOW INSUFFLATOR
K862310
Cabot Medical Corp.
Obstetrics & Gynecology · 56d

About Product Code HES - Regulatory Context