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
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 Dec 15, 2011
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
K102898
Panpac Medical Corporation
Obstetrics & Gynecology · 441d
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 Jun 07, 2010
PANPAC HSG CATHETER SET
K092983
Panpac Medical Corporation
Obstetrics & Gynecology · 252d
Cleared Apr 30, 2010
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
K092969
Sterling Medical, Inc.
Obstetrics & Gynecology · 217d
Cleared Apr 07, 2010
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
K092984
Panpac Medical Corporation
Obstetrics & Gynecology · 191d
Cleared Apr 07, 2010
FEMVUE CORNUAL BALLOON CATHETER
K100662
Femasys, Inc.
Obstetrics & Gynecology · 30d
Cleared Mar 12, 2010
VCARE DX
K093556
Conmed Corporation
Obstetrics & Gynecology · 115d
Cleared Mar 11, 2010
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
K092980
Panpac Medical Corporation
Obstetrics & Gynecology · 164d
Cleared Jul 21, 2009
EZ HSG CATHETER.FOAMSEAL CATHETER
K083594
Obg Products
Obstetrics & Gynecology · 228d
Cleared Jun 23, 2009
FEMVUE(TM) CATHETER SYSTEM
K083690
Femasys, Inc.
Obstetrics & Gynecology · 193d
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 22, 2004
SOFTSEAL HSG CATHETER
K040238
Modern Medical Equipment Mfg., Ltd.
Obstetrics & Gynecology · 148d
Cleared Jun 17, 2004
HSG CATHETER SET
K041094
Bioteque America, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 11, 2003
H/S CATHETER SET
K032835
Catheter Research, Inc.
Obstetrics & Gynecology · 91d
Cleared Dec 12, 2002
INTRAUTERINE DELIVERY SYSTEM - INJECTOR
K023051
Prosurg, Inc.
Obstetrics & Gynecology · 90d
Cleared Oct 25, 2002
UTERINE INJECTOR
K022503
Thomas Medical, Inc.
Obstetrics & Gynecology · 88d