FDA 510(k) Applications for Medical Device Product Code "KNA"
(Instrument, Manual, Specialized Obstetric-Gynecologic)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K062438 |
COOK OB/GYN |
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 |
10/27/2006 |
K013597 |
COOK OB/GYN |
TAMPONADE UTERINE BALLOON CATHETER SET |
04/17/2002 |
K952527 |
COOK UROLOGICAL, INC. |
BALLOON UTERINE STENT |
01/02/1996 |
K082939 |
COOK UROLOGICAL, INC. |
COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 |
09/03/2009 |
K102141 |
COOK UROLOGICAL, INC. |
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) |
05/06/2011 |
K060289 |
FRONTLINE MEDICAL |
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 |
07/07/2006 |
K093904 |
GLENVEIGH SURGICAL, LLC |
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER |
04/14/2010 |
K980237 |
GYNEX CORP. |
GYNEX ENDOSPECULUM |
04/08/1998 |
K990738 |
M.S. JAHANGER, MD |
DR. JAHANGER'S CUTTER |
10/29/1999 |
K972013 |
NATIONAL HEALTHCARE MFG. CORP. |
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS |
08/26/1997 |
K130087 |
Panpac Medical Corporation |
PANPAC WORD/BARTHOLIN CATHETER |
01/10/2014 |
K990045 |
POAMAX L.L.C. |
BERACLAMP, MODEL BC-1 |
05/24/1999 |
K971277 |
TALON MEDICAL, LTD. |
SAFE-T-CLAMP |
05/20/1997 |
K001590 |
UROGYN LTD. |
DND 101 |
08/02/2000 |
K014248 |
UROGYN LTD. |
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER |
03/21/2002 |
K980717 |
UROMED CORP. |
UROMED SLING KIT |
05/22/1998 |
K982464 |
WOMEN FIRST HEALTHCARE, INC. |
SCC-23 SAFETY CLAMP AND CUTTER |
08/11/1998 |
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