510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010068Substantially Equivalent

Rusch Polyflex Stent for the Esophagus with Introducer System

Rusch Intl., Jaffrey NH / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K010068 is the FDA 510(k) clearance record for RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM, a class II device, cleared for Rusch Intl. on under FDA product code ESW (Prosthesis, Esophageal). FDA records list 43 510(k) clearances for Rusch Intl., from to . As of , FDA records show 9 recalls naming K010068.

Clearance record

Decision date
Received
(31 days to decision)
Product code
ESW Prosthesis, Esophageal
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Rusch Intl. 50 Plantation Dr., Jaffrey NH
510(k) summary
Summary
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