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Argyle Universal Poole Suction Tube

by Sherwood Medical Co.

510(k) K803187

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 NumberK803187 Date9 Jan 1981ClearedStatusActive

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  • Withdrawn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
JOL
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 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 Universal Poole Suction Tube is a suction catheter and tip device. It is designed to facilitate the removal of fluids and debris from a surgical site or body cavity.

This device is classified under regulation 880.6740 and is intended for use in a general hospital setting. It has received FDA 510(k) clearance under the submission number K803187.

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Questions

AI-generated answers, 26 Sep 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 primary function of the Argyle Universal Poole Suction Tube?

    This device is a suction catheter and tip designed to facilitate the removal of fluids and debris from a surgical site or body cavity during medical procedures.

  • In what clinical environment is this suction tube intended to be used?

    The device is intended for use in a general hospital setting, as indicated by its classification under regulation 880.6740.

  • What is the regulatory status of this suction device?

    The Argyle Universal Poole Suction Tube has received FDA 510(k) clearance under submission number K803187, having been determined to be substantially equivalent to existing devices.