510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K933845Substantially Equivalent

Wilson-Cook Balloon Inflation Device

Wilson-Cook Medical Inc., West Lafayette IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933845 is the FDA 510(k) clearance record for WILSON-COOK BALLOON INFLATION DEVICE, 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 K933845.

Clearance record

Decision date
Received
(480 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. P.O.Box 2402, West Lafayette IN
510(k) summary
Summary
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