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Argyle Percussor System

by Sherwood Medical Industries

510(k) K771876

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 NumberK771876 Date28 Oct 1977ClearedStatusActive

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  • Withdrawn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)

Full name
Argyle Peocussor System
510(k) Number
FDA Product Code
BYI
Device Class
Class II
Regulation
21 CFR Part 868.5665
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Percussor System is a powered-electric percussor device designed for use in anesthesiology. It delivers mechanical percussion to assist in the removal of secretions or mucus from airways, aiding in patient airway clearance during medical procedures.

This system is supplied as a reusable device and is classified under FDA regulation 868.5665 as a Class II medical device. It was granted a 510(k) clearance (K771876) under the Traditional pathway in 1977, with the product code BYI. No specific sterility or MRI safety information is provided in the available data.

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Questions

AI-generated answers, 19 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 clinical purpose of the Argyle Percussor System in anesthesiology procedures?

    The Argyle Percussor System is designed to deliver mechanical percussion to help clear secretions or mucus from airways during medical procedures, specifically aiding in airway clearance for patients under anesthesia.

  • Is the Argyle Percussor System intended for single-use or reusable applications?

    The Argyle Percussor System is explicitly supplied as a reusable device, meaning it is intended for repeated use after proper cleaning and maintenance.

  • How many different models or variants of the Argyle Percussor System are listed in regulatory records?

    The system includes multiple registration numbers (e.g., 3011120183, 3004961434, etc.), suggesting there may be several model variants or configurations, though specific differences between them are not detailed in the provided data.

  • What regulatory pathway was followed for the FDA clearance of the Argyle Percussor System, and when was it granted?

    The Argyle Percussor System received FDA clearance under the Traditional 510(k) pathway in 1977, with the clearance number K771876, and was classified as substantially equivalent to a predicate device under FDA regulation 868.5665.

  • Are there any specific storage requirements mentioned for the Argyle Percussor System?

    The provided data does not include explicit storage instructions for the Argyle Percussor System, so standard medical device storage guidelines should be followed until further details are available.