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Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

by Ela Medical, Inc.

510(k) K952364

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)ST Traditional NumberK952364 Date1 Sep 1995DecidedStatusActive

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  • Withdrawn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
DXY
Models / Variants
4001
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
ST

Overview

AI-generated summary, 18 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 Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024) are implantable pacemaker pulse-generators designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when necessary. These devices are classified under the nomenclature for Implantable Pacemaker Pulse-Generators and are intended for patients with bradycardia or other conduction disorders requiring cardiac pacing.

These pacemakers are intended for surgical implantation by qualified healthcare professionals in clinical settings such as hospitals or cardiac care units. Each model is a reusable, sterile device, with specifications and regulatory compliance documented under FDA 510(k) clearance (K952364) and classified as Class III medical devices. They are subject to tracking regulations and fall under the cardiovascular specialty category, adhering to regulatory standards outlined in 21 CFR 870.3610.

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