Linder Nasotracheal Airway

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K881496 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Flextitip Stylette

  Class I

  FDA 510(k) K950380 Active Cleared 10 Feb 1995

• Linder Nasopharyngeal Airway

  Class I

  FDA 510(k) K843524 Active Cleared 4 Oct 1984

• Airguide Stylette

  Class I

  FDA 510(k) K950713 Active Cleared 17 May 1995

• Cricothyrotomy Tube

  Class II

  FDA 510(k) K983000 Active Cleared 27 Oct 1999

• Sureloc Circuit Connector

  Class I

  FDA 510(k) K954383 Active Cleared 22 Dec 1995

• Gastric, Catheter, Irrigation & Aspiration

  Class II

  FDA 510(k) K933596 Active Cleared 13 Feb 1995

See all devices from Polamedco, Inc. →

• What is the Linder Nasotracheal Airway used for?

  The Linder Nasotracheal Airway is designed for nasotracheal intubation to maintain a patent airway during anesthesiology procedures, as it is a tracheal tube with or without connector intended for clinical use.

• Is the Linder Nasotracheal Airway sterile or non-sterile, and is it reusable?

  The device is supplied as non-sterile and is intended for reuse in clinical settings, meaning it must be cleaned and sterilized by the user before each application according to institutional protocols.

• What regulatory clearance does the Linder Nasotracheal Airway have?

  The Linder Nasotracheal Airway has received FDA 510(k) clearance under submission K881496 and is classified as a Class II medical device under regulation number 868.5730.