RUTTER SUPRA STOMAL STENTS

• K Number: K091135
• Device Name: RUTTER SUPRA STOMAL STENTS
• Manufacturer: BOSTON MEDICAL PRODUCTS, INC.
• Date Cleared: 2009-09-14 ( 147 days)
• Product Code: FWN
• Regulation Number: 874.3620
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: N/A

Intended Use

The Rutler Supra Stomal Stent is indicated for the prevention and treatment of laryngeal and tracheal stenosis.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) substantially equivalent letter from the FDA regarding the "Rutter Supra Stomal Stents." It does not contain information about acceptance criteria, device performance metrics, or study details. It is a regulatory approval letter.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and the substantial equivalence determination, not on a detailed scientific study supporting device performance.

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.