510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851965Substantially Equivalent

Wilson-Cook Stone Extractor

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

K851965 is the FDA 510(k) clearance record for WILSON-COOK STONE EXTRACTOR, a class II device, cleared for Wilson-Cook Medical, Inc. on under FDA product code FFL (Dislodger, Stone, Basket, Ureteral, Metal). FDA records list 131 510(k) clearances for Wilson-Cook Medical, Inc., from to . As of , FDA records show no recalls naming K851965.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FFL Dislodger, Stone, Basket, Ureteral, Metal
Regulation
21 CFR 876.4680
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 FFL

Trailing 12 months

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

FDA records show no clearances under product code FFL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFL, 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