510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020526Substantially Equivalent

Modification to Wilson-Cook Multiple Band Ligator

Don Wilson/Wilson-Cook Medical, Inc., Winston-Salem NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020526 is the FDA 510(k) clearance record for MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR, a class II device, cleared for Don Wilson/Wilson-Cook Medical, Inc. on under FDA product code FHN (Ligator, Hemorrhoidal). FDA records list one 510(k) clearance for Don Wilson/Wilson-Cook Medical, Inc. As of , FDA records show no recalls naming K020526.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FHN Ligator, Hemorrhoidal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Don Wilson/Wilson-Cook Medical, Inc. 4900 Bethanaia Station Rd., Winston-Salem NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FHN

Trailing 12 months

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

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