Medical Device Manufacturer · US , Winston-Salem , NC

Wiltek Medical, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1989
21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Wiltek Medical, Inc. Gastroenterology & Urology

16 devices
1-16 of 16
Cleared Apr 13, 1999
WILTEK HOT BIOPSY FORCEPS
K990231 · KGE
Gastroenterology & Urology · 78d
Cleared Jan 07, 1992
WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K914881 · FGE
Gastroenterology & Urology · 69d
Cleared Jan 07, 1992
WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
K914882 · FGE
Gastroenterology & Urology · 69d
Cleared Sep 23, 1991
CHOLANGIOGRAPHY CATHETER
K912122 · FGE
Gastroenterology & Urology · 132d
Cleared Sep 23, 1991
WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
K912288 · FGE
Gastroenterology & Urology · 123d
Cleared Dec 21, 1989
WILTEK GASTRIC FEEDING TUBE
K894860 · FPD
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK PAPILLOTOME
K894861 · KNS
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK GRASPING FORCEPS
K894862 · OCZ
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK CYTOLOGY BRUSH
K894863 · FDX
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BALLOON STONE EXTRACTOR
K894865 · LQR
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK STONE EXTRACTOR
K894866 · LQR
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK E.R.C.P. CATHETER
K894867 · FGE
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK VARICES INJECTION NEEDLE
K894868 · FBK
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK POLYPECTOMY SNARE
K894869 · FDI
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK NASAL BILIARY DRAINAGE SET
K894870 · BSS
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK BILIARY STENT SET
K894871 · FGE
Gastroenterology & Urology · 143d
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