LKF · Class II · 21 CFR 884.4530

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

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

87
Total
87
Cleared
194d
Avg days
1978
Since
87 devices
25–48 of 87
Cleared Dec 11, 2013
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER
K130758
Kronner Prototypes, Inc.
Obstetrics & Gynecology · 266d
Cleared Jun 18, 2013
VIKY UP
K122820
Endocontrol
Obstetrics & Gynecology · 277d
Cleared Jan 31, 2013
THE ADVANCE CATHETER FOR HSG AND SIS
K123258
Catheter Research, Inc.
Obstetrics & Gynecology · 105d
Cleared Oct 12, 2011
FEMCHEC PRESSURE MANAGEMET DEVICE
K110993
Femasys, Inc.
Obstetrics & Gynecology · 187d
Cleared Apr 28, 2011
FEMVUE SALINE-AIR DEVICE
K110288
Femasys, Inc.
Obstetrics & Gynecology · 86d
Cleared Mar 12, 2010
VCARE DX
K093556
Conmed Corporation
Obstetrics & Gynecology · 115d
Cleared Oct 09, 2007
PROBE HOLDER SYSTEM
K071405
Intuitive Surgical, Inc.
Obstetrics & Gynecology · 141d
Cleared Oct 05, 2007
VCARE RETRACTOR/ELEVATOR
K071907
Conmed Corporation
Obstetrics & Gynecology · 87d
Cleared May 23, 2007
SALINE/ CONTRAST MEDIA INFUSION CATHETER
K063611
Utah Medical Products, Inc.
Obstetrics & Gynecology · 171d
Cleared Oct 13, 2006
WALLACE ARTIFICIAL INSEMINATION CATHETER
K061679
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 120d
Cleared Oct 01, 2004
INTRAUTERINE VENOGRAM NEEDLE SET
K041062
Cook Urological, Inc.
Obstetrics & Gynecology · 161d
Cleared Jun 17, 2004
HSG CATHETER SET
K041094
Bioteque America, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 12, 2002
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
K023051
Prosurg, Inc.
Obstetrics & Gynecology · 90d
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 16, 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951
Ackrad Laboratories
Obstetrics & Gynecology · 22d
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 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 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