510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013356Substantially Equivalent

Wilson-Cook Ultrasound Biopsy Needle

Wilson-Cook Medical Inc., Winston-Salem NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K013356 is the FDA 510(k) clearance record for WILSON-COOK ULTRASOUND BIOPSY NEEDLE, a class II device, cleared for Wilson-Cook Medical, Inc. on under FDA product code FCG (Biopsy Needle). FDA records list 131 510(k) clearances for Wilson-Cook Medical, Inc., from to . As of , FDA records show one recall naming K013356.

Clearance record

Decision date
Received
(9 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Wilson-Cook Medical, Inc. 4900 Bethania Station Rd., Winston-Salem NC
510(k) summary
Summary
Third party review
No

Clearances, product code FCG

Trailing 12 months

FDA records hold no clearances under product code FCG in the trailing twelve months.

FDA records show no clearances under product code FCG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260