KNA · Class II · 21 CFR 884.4530

FDA Product Code KNA: Instrument, Manual, Specialized Obstetric-gynecologic

Leading manufacturers include Zinnanti Surgical Instruments, Inc., Thomasville Medical Assoc. and Cook Urological, Inc..

58
Total
58
Cleared
144d
Avg days
1977
Since

FDA 510(k) Cleared Instrument, Manual, Specialized Obstetric-gynecologic Devices (Product Code KNA)

58 devices
1–24 of 58
Cleared Jan 10, 2014
PANPAC WORD/BARTHOLIN CATHETER
K130087
Panpac Medical Corporation
Obstetrics & Gynecology · 361d
Cleared May 06, 2011
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
K102141
Cook Urological, Inc.
Obstetrics & Gynecology · 281d
Cleared Apr 14, 2010
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
K093904
Glenveigh Surgical, LLC
Obstetrics & Gynecology · 113d
Cleared Sep 03, 2009
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
K082939
Cook Urological, Inc.
Obstetrics & Gynecology · 336d
Cleared Oct 27, 2006
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
K062438
Cook Ob/Gyn
Obstetrics & Gynecology · 67d
Cleared Jul 07, 2006
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
K060289
Frontline Medical
Obstetrics & Gynecology · 151d
Cleared Apr 17, 2002
TAMPONADE UTERINE BALLOON CATHETER SET
K013597
Cook Ob/Gyn
Obstetrics & Gynecology · 168d
Cleared Mar 21, 2002
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER
K014248
Urogyn , Ltd.
Obstetrics & Gynecology · 85d
Cleared Aug 02, 2000
DND 101
K001590
Urogyn , Ltd.
Obstetrics & Gynecology · 77d
Cleared Oct 29, 1999
DR. JAHANGER'S CUTTER
K990738
M.S. Jahanger, MD
Obstetrics & Gynecology · 238d
Cleared May 24, 1999
BERACLAMP, MODEL BC-1
K990045
Poamax LLC
Obstetrics & Gynecology · 138d
Cleared Aug 11, 1998
SCC-23 SAFETY CLAMP AND CUTTER
K982464
Women First Healthcare, Inc.
Obstetrics & Gynecology · 27d
Cleared May 22, 1998
UROMED SLING KIT
K980717
Uromed Corp.
Obstetrics & Gynecology · 87d
Cleared Apr 08, 1998
GYNEX ENDOSPECULUM
K980237
Gynex Corp.
Obstetrics & Gynecology · 75d
Cleared Aug 26, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS
K972013
National Healthcare Mfg. Corp.
Obstetrics & Gynecology · 88d
Cleared May 20, 1997
SAFE-T-CLAMP
K971277
Talon Medical, Ltd.
Obstetrics & Gynecology · 43d
Cleared Jan 02, 1996
BALLOON UTERINE STENT
K952527
Cook Urological, Inc.
Obstetrics & Gynecology · 215d
Cleared Dec 21, 1995
CORDGUARD II
K954619
Utah Medical Products, Inc.
Obstetrics & Gynecology · 77d
Cleared Nov 13, 1995
OB/GYN PACKS
K951081
Sterile Concepts, Inc.
Obstetrics & Gynecology · 249d
Cleared Dec 29, 1994
MADDEN SURGICAL THIMBLE
K940907
Kelley-Gilmer Medical Corp.
Obstetrics & Gynecology · 308d
Cleared Oct 03, 1994
DISPOSABLE EMERGENCY OBSTETRICAL KIT
K941641
Gam Industries, Inc.
Obstetrics & Gynecology · 182d
Cleared Feb 25, 1994
ENDO CERVICAL CURETTE
K926532
Thomasville Medical Assoc.
Obstetrics & Gynecology · 422d
Cleared Feb 24, 1994
Z CLAMP SCISSORS
K926529
Thomasville Medical Assoc.
Obstetrics & Gynecology · 421d
Cleared Feb 24, 1994
MIYA HOOK
K926530
Thomasville Medical Assoc.
Obstetrics & Gynecology · 421d

About Product Code KNA - Regulatory Context