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Argyle Jet Tracheal Tube

by Sherwood Medical Co.

510(k) K833807

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833807 Date13 Jan 1984ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTR
Device Class
Class II
Regulation
21 CFR Part 868.5730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Argyle Jet Tracheal Tube is a Class 2 medical device used in anesthesiology procedures. It is designed for tracheal intubation and functions as a jet tube for airway management during surgical or emergency situations.

The device is manufactured by Sherwood Medical Co. and is supplied in various sizes as indicated by the multiple registration numbers. It received FDA 510(k) clearance on January 13, 1984, with product code BTR, and is regulated under 868.5730. The device is not specified as single-use or reusable in the provided data.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Argyle Jet Tracheal Tube used for?

    The Argyle Jet Tracheal Tube is a Class 2 medical device designed for tracheal intubation and functions as a jet tube for airway management during surgical or emergency situations in anesthesiology procedures.

  • Is the Argyle Jet Tracheal Tube single-use or reusable?

    The provided data does not specify whether the Argyle Jet Tracheal Tube is designed for single-use or reusable purposes. Clinicians should consult the manufacturer's instructions for use to determine the appropriate handling protocol.

  • What sizes are available for the Argyle Jet Tracheal Tube?

    The Argyle Jet Tracheal Tube is supplied in various sizes as indicated by the multiple registration numbers provided in the device data. The specific size options should be confirmed with the manufacturer or product documentation.

  • What is the regulatory status of the Argyle Jet Tracheal Tube?

    The Argyle Jet Tracheal Tube received FDA 510(k) clearance on January 13, 1984, with product code BTR, and is regulated under 868.5730. It is classified as a Class 2 medical device and was determined to be substantially equivalent to predicate devices.