510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982614Substantially Equivalent

Rusch Polyflex Stent Kit

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

K982614 is the FDA 510(k) clearance record for RUSCH POLYFLEX STENT KIT, a class II device, cleared for Rusch Intl. on under FDA product code NYT (Prosthesis, Tracheal, Expandable, Polymeric). FDA's definition for product code NYT reads: "The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have...". FDA records list 43 510(k) clearances for Rusch Intl., from to . As of , FDA records show no recalls naming K982614.

Clearance record

Decision date
Received
(130 days to decision)
Product code
NYT Prosthesis, Tracheal, Expandable, Polymeric
Regulation
21 CFR 878.3720
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Rusch Intl. Tall Pines Park, Jeffrey NH
510(k) summary
Summary
Third party review
No

Clearances, product code NYT

Trailing 12 months

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

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