Medical Device Manufacturer · US , Winston-Salem , NC

Wiltek Medical, Inc.

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

Wiltek Medical, Inc. — FDA 510(k) Submissions

Wiltek Medical, Inc. has submitted 21 FDA 510(k) premarket notifications since 1989, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Stents, Drains And Dilators For The Biliary Ducts, Electrosurgical, Cutting & Coagulation & Accessories, Dislodger, Stone, Biliary, Tube, Aspirating, Flexible, Connecting, Tube, Feeding . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
WILTEK HOT BIOPSY FORCEPS
K990231 · KGE Forceps, Biopsy, Electric · Gastroenterology & Urology
Apr 1999 78d
WILTEK IRRIGAITON/ASPIRATION TUBE SET
K922989 · BYY Tube, Aspirating,... · General Hospital
Feb 1994 603d
WILTEK BIOPSY FORCEPS
K930419 · BWH Forceps, Biopsy,... · Ear, Nose, Throat
Jun 1993 126d
WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K914881 · FGE Stents, Drains And... · Gastroenterology & Urology
Jan 1992 69d
WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
K914882 · FGE Stents, Drains And... · Gastroenterology & Urology
Jan 1992 69d
WILTEK ELECTROCAUTERY ADAPTOR
K914131 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 1991 12d
WILTEK ELECTROCAUTERY ACTIVE CORD
K914132 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 1991 12d
CHOLANGIOGRAPHY CATHETER
K912122 · FGE Stents, Drains And... · Gastroenterology & Urology
Sep 1991 132d
WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
K912288 · FGE Stents, Drains And... · Gastroenterology & Urology
Sep 1991 123d
ELECTROCAUTERY PROBE
K910334 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 1991 27d
WILTEK GASTRIC FEEDING TUBE
K894860 · FPD Tube, Feeding · Gastroenterology & Urology
Dec 1989 143d
WILTEK PAPILLOTOME
K894861 · KNS Unit, Electrosurgical,... · Gastroenterology & Urology
Dec 1989 143d
WILTEK GRASPING FORCEPS
K894862 · OCZ Endoscopic... · Gastroenterology & Urology
Dec 1989 143d
WILTEK CYTOLOGY BRUSH
K894863 · FDX Endoscopic Cytology Brush · Gastroenterology & Urology
Dec 1989 143d
WILTEK BALLOON STONE EXTRACTOR
K894865 · LQR Dislodger, Stone, Biliary · Gastroenterology & Urology
Dec 1989 143d
WILTEK STONE EXTRACTOR
K894866 · LQR Dislodger, Stone, Biliary · Gastroenterology & Urology
Dec 1989 143d
WILTEK E.R.C.P. CATHETER
K894867 · FGE Stents, Drains And... · Gastroenterology & Urology
Dec 1989 143d
WILTEK VARICES INJECTION NEEDLE
K894868 · FBK Endoscopic Injection... · Gastroenterology & Urology
Dec 1989 143d
WILTEK POLYPECTOMY SNARE
K894869 · FDI Snare, Flexible · Gastroenterology & Urology
Dec 1989 143d
WILTEK NASAL BILIARY DRAINAGE SET
K894870 · BSS Tube, Nasogastric · Gastroenterology & Urology
Dec 1989 143d
WILTEK BILIARY STENT SET
K894871 · FGE Stents, Drains And... · Gastroenterology & Urology
Dec 1989 143d
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