510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182895Substantially Equivalent

Wilson-Cook Achalasia Balloon

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

K182895 is the FDA 510(k) clearance record for Wilson-Cook Achalasia Balloon, a class II device, cleared for Wilson-Cook Medical, Inc. on under FDA product code PID (Esophageal Dilator Balloon With Or Without Electrode Sensors). FDA's definition for product code PID reads: "To dilate the lower esophageal sphincter of patients with Achalasia". FDA records list 131 510(k) clearances for Wilson-Cook Medical, Inc., from to . As of , FDA records show no recalls naming K182895.

Clearance record

Decision date
Received
(102 days to decision)
Product code
PID Esophageal Dilator Balloon With Or Without Electrode Sensors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Wilson-Cook Medical, Inc. 4900 Bethania Station Rd., Winston-Salem NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PID

Trailing 12 months

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

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