Slick Set W/Sureloc External Connector

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

510(k) Number

K810151 ↗

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

• Linder Nasotracheal Airway

  Class II

  FDA 510(k) K881496 Active Cleared 31 May 1988

• 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

See all devices from Polamedco, Inc. →

• What clinical settings is the Slick Set with Sureloc External Connector designed for use in, and why is this important?

  The Slick Set with Sureloc External Connector is designed for use in clinical settings such as operating rooms and intensive care units. This is important because these environments require reliable airway management during procedures like anesthesia or mechanical ventilation, where stable airflow is critical for patient safety and treatment efficacy.

• Is the Slick Set with Sureloc External Connector intended for single-use or reusable applications, and how does this affect its handling?

  The Slick Set with Sureloc External Connector is explicitly supplied as a single-use, sterile product. This means it must be discarded after one use to maintain sterility and prevent cross-contamination, requiring strict adherence to sterile medical device handling protocols during and after use.

• What sizes are available for the Slick Set with Sureloc External Connector, and how does this impact patient compatibility?

  The device is available in multiple sizes, including Size 4.5, among others (as referenced by the listed FEI numbers). This variability allows for better patient compatibility, ensuring appropriate sizing for different age groups or anatomical needs during airway management procedures.

• How does the Sureloc External Connector improve reliability in clinical use, and what accessories can be paired with it?

  The Sureloc External Connector is designed to provide a secure attachment to breathing circuits or ventilators, ensuring stable airflow during critical procedures like anesthesia or mechanical ventilation. It can be paired with optional stylette guides to enhance insertion accuracy and ease of use.

• What storage and handling guidelines should be followed for the Slick Set with Sureloc External Connector to maintain its integrity?

  The device follows standard sterile medical device protocols for storage and handling. This includes maintaining sterility until first use, proper packaging integrity, and adherence to manufacturer instructions to prevent contamination or damage before and during clinical application.