Medical Device Manufacturer · US , Mchenry , IL

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

163 submissions · 148 cleared · Since 1980
163
Total
148
Cleared
0
Denied
61 devices
26-50 of 61
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 Jul 29, 1999
GORE-TEX DUALMESH BIOMATERIAL
K992189 · FTL
General & Plastic Surgery · 30d
Cleared Apr 15, 1998
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K981051 · FTL
General & Plastic Surgery · 28d
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 Sep 03, 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401 · FTL
General & Plastic Surgery · 74d
Cleared Jun 19, 1996
SAM FACIAL IMPLANT
K961210 · LZK
General & Plastic Surgery · 83d
Cleared Feb 01, 1996
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K955364 · OXD
General & Plastic Surgery · 71d
Cleared Jan 24, 1996
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
K955494 · FTL
General & Plastic Surgery · 54d
Cleared Nov 14, 1995
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
K952898 · FTL
General & Plastic Surgery · 144d
Cleared Oct 07, 1995
GORE-TEX MYCROMESH BIOMATERIAL
K951675 · FTL
General & Plastic Surgery · 179d
Cleared Oct 07, 1995
GORE-TEX DUALMESH BIOMATERIAL
K951676 · FTL
General & Plastic Surgery · 179d
Cleared Oct 07, 1995
GORE-TEX SOFT TISSUE PATCH
K951700 · FTL
General & Plastic Surgery · 178d
Cleared Apr 24, 1995
GORE-TEX DUALMESH PLUS BIOMATERIAL
K946106 · FTL
General & Plastic Surgery · 131d
Cleared Apr 24, 1995
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K946107 · FTL
General & Plastic Surgery · 131d
Cleared Mar 22, 1995
GORE-TEX SAM FACIAL IMPLANT
K946267 · FWP
General & Plastic Surgery · 89d
Cleared Mar 03, 1995
GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE)
K945953 · GCJ
General & Plastic Surgery · 87d
Cleared Feb 13, 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · FTL
General & Plastic Surgery · 73d
Cleared Sep 29, 1994
GORE-TEX SOFT TISSUE PATCH PLUS
K922452 · FTL
General & Plastic Surgery · 856d
Cleared Jul 28, 1994
GORE-TEX FACIAL IMPLANT
K933367 · FWP
General & Plastic Surgery · 384d
Cleared Jul 28, 1994
GORETEX SAM FACIAL IMPLANT
K942280 · FWP
General & Plastic Surgery · 79d
Cleared May 12, 1994
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · GCJ
General & Plastic Surgery · 149d
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