510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K900924Substantially Equivalent

Wilson-Cook Balloon Dilation Catheters

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

K900924 is the FDA 510(k) clearance record for WILSON-COOK BALLOON DILATION CATHETERS, a class II device, cleared for Wilson-Cook Medical, Inc. on under FDA product code KNQ (Dilator, Esophageal). FDA records list 131 510(k) clearances for Wilson-Cook Medical, Inc., from to . As of , FDA records show no recalls naming K900924.

Clearance record

Decision date
Received
(297 days to decision)
Product code
KNQ Dilator, Esophageal
Regulation
21 CFR 876.5365
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 KNQ

Trailing 12 months

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

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