510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223266Substantially Equivalent

Hilzo Esophageal Stents

Thoracent LLC, Huntington NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223266 is the FDA 510(k) clearance record for Hilzo Esophageal Stents, a class II device, cleared for Thoracent, Inc. on under FDA product code ESW (Prosthesis, Esophageal). FDA records list one 510(k) clearance for Thoracent, Inc. As of , FDA records show no recalls naming K223266.

Clearance record

Decision date
Received
(449 days to decision)
Product code
ESW Prosthesis, Esophageal
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Thoracent, Inc. 120 New York Ave., Huntington NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ESW

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