510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895900Substantially Equivalent

Wilson-Cook Biliary and Gastric Aspiration Needle

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

K895900 is the FDA 510(k) clearance record for WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE, a class II device, cleared for Wilson-Cook Medical, Inc. on under FDA product code FCK (Instrument, Biopsy, Suction). FDA records list 131 510(k) clearances for Wilson-Cook Medical, Inc., from to . As of , FDA records show no recalls naming K895900.

Clearance record

Decision date
Received
(97 days to decision)
Product code
FCK Instrument, Biopsy, Suction
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
Third party review
No

Clearances, product code FCK

Trailing 12 months

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

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