510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K885309Substantially Equivalent

Wilson-Cook Esophageal Balloon Prosthesis

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

K885309 is the FDA 510(k) clearance record for WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS, a class II device, cleared for Wilson-Cook Medical, Inc. on under FDA product code ESW (Prosthesis, Esophageal). FDA records list 131 510(k) clearances for Wilson-Cook Medical, Inc., from to . As of , FDA records show no recalls naming K885309.

Clearance record

Decision date
Received
(408 days to decision)
Product code
ESW Prosthesis, Esophageal
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Wilson-Cook Medical, Inc. 4900 Bethania Station Rd. &, Winston-Salem NC
Third party review
No

Clearances, product code ESW

Trailing 12 months
1 clearance under product code ESW in the twelve months to November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ESW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260