FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

WILSON-COOK PULL THROUGH PEG KIT

K Number: K901163 · Decision Nov 19, 1990
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
125
Review Days
251

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Basic Information

Device Name
WILSON-COOK PULL THROUGH PEG KIT
K Number
K901163
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5980
Medical Specialty
Gastroenterology, Urology
Decision
Unknown
Applicant
Wilson-Cook Medical, Inc.
Date Received
March 13, 1990
Decision Date
November 19, 1990
Product Code
FPD
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FPD Tube, Feeding

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K200972 Hemospray Endoscopic Hemostat
K200247 Fusion Quattro Extraction Balloon
K192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord
K193344 Tri-Ex Extraction Balloon with Multiple Sizing
K192908 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
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