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Hall Arterial Oscillator

by American Sterilizer Co.

510(k) K801063

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801063 Date26 Sep 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DWX
Device Class
Class II
Regulation
21 CFR Part 870.4875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Hall Arterial Oscillator is a Stripper, Artery, Intraluminal device classified under the Cardiovascular medical specialty. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.

The device was cleared under product code DWX and regulation number 870.4875. It was manufactured by American Sterilizer Co. and received FDA 510(k) clearance on September 26, 1980, with application received on May 6, 1980.

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Questions

AI-generated answers, 1 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 Hall Arterial Oscillator used for?

    The Hall Arterial Oscillator is designed as an intraluminal artery stripper device, used within the cardiovascular specialty to remove material from inside arteries during surgical procedures, based on its classification as a Stripper, Artery, Intraluminal device.

  • How is the Hall Arterial Oscillator supplied and is it reusable?

    The device data does not specify whether the Hall Arterial Oscillator is supplied sterile or non-sterile, or if it is intended for single-use or reuse; therefore, no determination about its supply format or reusability can be made from the provided information.

  • What regulatory pathway was used for the Hall Arterial Oscillator?

    The Hall Arterial Oscillator received FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to a predicate device, with clearance granted on September 26, 1980, under application number K801063.