W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices

Cleared Jan 08, 2002

VIABAHN ENDOPROSTHESIS

K013648 · JCT

General & Plastic Surgery · 64d

Cleared Dec 19, 2001

GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE

K013346 · LYC

Dental · 71d

Cleared Dec 14, 2001

GORE INTRODUCER SHEATH

K013282 · DBY

Immunology · 73d

Cleared Nov 27, 2001

CARDIOVASCULAR ARRAY

K013810 · MOS

Radiology · 12d

Cleared Oct 26, 2001

GORE-TEX VASCULAR GRAFT

K013250 · DSY

Cardiovascular · 28d

Cleared Sep 20, 2001

PRECLUDE PERICARDIAL MEMBRANE

K012098 · DXZ

Cardiovascular · 77d

Cleared May 21, 2001

MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

K010936 · OXD

General & Plastic Surgery · 54d

Cleared Feb 21, 2001

GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES

K010228 · FTL

General & Plastic Surgery · 28d

Cleared Jul 06, 2000

SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

K001789 · OXD

General & Plastic Surgery · 23d

Cleared Feb 14, 2000

GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)

K000185 · FTL

General & Plastic Surgery · 25d

Cleared Sep 08, 1999

PTFE RINGED GORE-TEX VASCULAR GRAFT

K991683 · DYF

Cardiovascular · 114d

Cleared Jul 29, 1999

GORE-TEX DUALMESH BIOMATERIAL

K992189 · FTL

General & Plastic Surgery · 30d

Cleared Jul 09, 1999

EPTFE RINGED GORE-TEX VASCULAR GRAFT

K991602 · DSY

Cardiovascular · 60d

Cleared Apr 08, 1999

ACUSEAL CARDIOVASCULAR PATCH

K984526 · DXZ

Cardiovascular · 108d

Cleared Mar 15, 1999

PRECLUDE ACUSEAL DURA SUBSTITUTE

K984534 · GXQ

Neurology · 84d

Cleared Dec 10, 1998

GORE REVOX THYROPLASTY IMPLANT

K983525 · MIX

Ear, Nose, Throat · 63d

Cleared Apr 15, 1998

SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES

K981051 · FTL

General & Plastic Surgery · 28d

Cleared Dec 17, 1997

GORE RESOLUT XT REGENERATIVE MATERIAL

K973594 · LYC

Dental · 86d

Cleared Jun 05, 1997

GORE IRRIGATION SET

K964067 · FPA

General Hospital · 238d

Cleared May 08, 1997

RESOLUT REGENERATIVE MATERIAL

K970884 · LYC

Dental · 59d

Cleared Feb 20, 1997

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

K964061 · LYK

Cardiovascular · 133d

Cleared Feb 06, 1997

GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS...

K965038 · FTL

General & Plastic Surgery · 51d

Cleared Jan 27, 1997

S.A.M. FACIAL IMPLANT W/INTRODUCER

K964761 · FTL

General & Plastic Surgery · 61d

Cleared Oct 25, 1996

GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH...

K963619 · FTL

General & Plastic Surgery · 45d

Cleared Oct 03, 1996

RESOLUT REGENERATIVE MATERIAL

K962624 · LYC

Dental · 90d