HES · Class II · 21 CFR 884.1300

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

Leading manufacturers include Cabot Medical Corp., Zinnanti Surgical Instruments, Inc. and C.R. Bard, Inc..

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 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