LKF · Class II · 21 CFR 884.4530

FDA Product Code LKF: Cannula, Manipulator/injector, Uterine

Leading manufacturers include Femasys, Inc., Ackrad Laboratories and Cook Incorporated.

87
Total
87
Cleared
194d
Avg days
1978
Since
87 devices
49–72 of 87
Cleared May 21, 2002
SIB CATHETER, MODEL 61-7005
K021272
Ackrad Laboratories
Obstetrics & Gynecology · 29d
Cleared Apr 24, 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
K020954
Ackrad Laboratories
Obstetrics & Gynecology · 30d
Cleared Apr 17, 2002
UTERINE INJECTOR
K020292
Catheter Research, Inc.
Obstetrics & Gynecology · 79d
Cleared Apr 16, 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951
Ackrad Laboratories
Obstetrics & Gynecology · 22d
Cleared Dec 17, 2001
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
K013972
Ackard Laboratories
Obstetrics & Gynecology · 14d
Cleared Nov 19, 2001
SF SH CATHETER, MODEL R65-945
K013437
A & A Medical, Inc.
Obstetrics & Gynecology · 33d
Cleared Nov 19, 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491
A & A Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Apr 11, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450
K010296
Marina Medical Instruments, Inc.
Obstetrics & Gynecology · 70d
Cleared Feb 01, 2001
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
K010056
A & A Medical, Inc.
Obstetrics & Gynecology · 24d
Cleared Jun 16, 2000
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433
Medical Device Technologies, Inc.
Obstetrics & Gynecology · 128d
Cleared May 17, 2000
ULTRA CATHETER SET
K001115
Lyco Enterprises, Inc.
Obstetrics & Gynecology · 41d
Cleared Feb 02, 1998
UTERINE MANIPULATOR/INJECTOR
K974357
Catheter Research, Inc.
Obstetrics & Gynecology · 75d
Cleared Apr 09, 1997
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
K970492
Ackrad Laboratories
Obstetrics & Gynecology · 58d
Cleared Aug 08, 1996
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K961752
Ackrad Laboratories
Obstetrics & Gynecology · 94d
Cleared Jun 18, 1996
CONMED VCARE RETRACTOR/ELEVATOR
K955446
Conmedcorp
Obstetrics & Gynecology · 202d
Cleared Feb 26, 1996
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
K955508
Cook Urological, Inc.
Obstetrics & Gynecology · 87d
Cleared Sep 15, 1995
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR
K946220
Conmedcorp
Obstetrics & Gynecology · 268d
Cleared Aug 29, 1995
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K953034
Ackrad Laboratories
Obstetrics & Gynecology · 71d
Cleared Jul 06, 1995
HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY
K943494
Lyco Enterprises, Inc.
Obstetrics & Gynecology · 352d
Cleared Jun 22, 1995
OVAMED FALLOPIAN OSTIAL ACCESS CATHETER
K931167
Ovamed Corp.
Obstetrics & Gynecology · 836d
Cleared Apr 11, 1995
LUMIN
K943448
Utah Medical Products, Inc.
Obstetrics & Gynecology · 267d
Cleared Jan 30, 1995
OVAMED HSG CATHETER
K931122
Ovamed Corp.
Obstetrics & Gynecology · 697d
Cleared Jan 26, 1995
BERNSTEIN(TM) UTERINE MANIPULATOR
K932394
Gm Engineering, Inc.
Obstetrics & Gynecology · 618d
Cleared Jan 25, 1995
UTERINE MANIPULATOR/INJECTOR WITH SPRING
K941458
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 306d