Rusch Tracheal Bronchial Y Stent

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K953593 ↗

FDA Product Code

NYT

Device Class

Class II

Regulation

21 CFR Part 878.3720

Advisory Committee

General, Plastic Surgery

FDA Decision

ST

• Rusch Safety Clear Uncuffed with Magill Tip

  Class II

  FDA 510(k) K925507 Active Cleared 2 Sep 1993

• Rusch Agt Pvc Pref Oral Trach Tube, Uncuf W/Mur Ey Open recall

  Class II

  FDA 510(k) K931166 Active Cleared 22 Jun 1993

• Rusch Agt Pvc Pref Nasal Trach Tub/Uncuf W/Mur Eye Open recall

  Class II

  FDA 510(k) K931165 Active Cleared 22 Jun 1993

• Rusch Lasertubus/Rusch Laser Resistant Cuffed with Murphy Eye

  Class II

  FDA 510(k) K935842 Active Cleared 23 May 1995

• Rusch Simplastic Foley Catheterization Set

  Class II

  FDA 510(k) K963993 Active Cleared 17 Dec 1996

• Rusch Mmg/O'neil Catheter Open recall

  Class II

  FDA 510(k) K010420 Active Cleared 9 May 2001

See all devices from Rusch, Inc. →

• What is the Rusch Tracheal Bronchial Y Stent used for?

  The Rusch Tracheal Bronchial Y Stent is a bifurcated, expandable prosthesis intended to maintain airway patency in the trachea and mainstem bronchi. It is specifically designed to address tracheal stenosis (narrowing of the airway) or to seal tracheoesophageal fistulas (abnormal connections between the trachea and esophagus). Its expandable design allows it to adapt to the anatomical contours of the airway, providing sustained support where obstruction or abnormal connections require intervention.

• Is the Rusch Tracheal Bronchial Y Stent single-use or reusable?

  The Rusch Tracheal Bronchial Y Stent is supplied as a single-use device. This classification ensures sterility and safety for one-time clinical use, reducing the risk of cross-contamination and maintaining optimal performance for the intended procedure. Reuse is not recommended or supported by the manufacturer.

• What material is the stent made from, and how does it function?

  The stent is constructed from a polymeric material, which provides flexibility and durability for airway support. Its expandable design allows it to be deployed and conform to the anatomical shape of the trachea and bronchi, ensuring a secure fit. This adaptability helps stabilize airway anatomy while addressing conditions like stenosis or fistulas, maintaining long-term patency.

• How should the Rusch Tracheal Bronchial Y Stent be stored?

  The stent should be stored according to standard sterile medical device protocols as outlined by the manufacturer. This typically involves keeping it in its original, sealed packaging in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Proper storage ensures sterility and maintains the device’s integrity until use.

• Does the Rusch Tracheal Bronchial Y Stent have any specific regulatory approvals?

  The device holds FDA 510(k) clearance under the reference number K953593, indicating it has been deemed substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under FDA product code NYT, which means it is subject to special controls to ensure its safety and effectiveness for its intended use in maintaining airway patency.