Opus Pulse Generators Models 2001, 2003, and 2004 - 2001

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

510(k) Number

K882474 ↗

FDA Product Code

DXY

Models / Variants

2001

2003

2004

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

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

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

• Opus Models 4033 and 4034 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K894267 Active Cleared 20 Sep 1989

See all devices from Ela Medical, Inc. →

• Are the Opus Pulse Generators Models 2001, 2003, and 2004 designed for reuse or single-use, and how does this affect their handling in the operating room?

  The Opus Pulse Generators Models 2001, 2003, and 2004 are supplied sterile and intended for single-use implantation only. This means they are not meant to be removed, cleaned, or reused after surgery. Clinicians must handle them as sterile, single-use devices to maintain patient safety and regulatory compliance, ensuring proper disposal after use.

• What are the key differences between the Opus Pulse Generator Models 2001, 2003, and 2004 in terms of their regulatory and functional classification?

  While the Opus Pulse Generators Models 2001, 2003, and 2004 are all implantable pacemaker pulse-generators, they are each uniquely identified by their reference codes and collectively fall under FDA 510(k) clearance (K882474) as Class III devices. Their classification as substantially equivalent (SESE) under 21 CFR 870.3610 confirms they meet regulatory standards for life-sustaining cardiac rhythm regulation, but individual model specifications (e.g., battery life, programming features) are not detailed in the provided data.

• How should these devices be stored before implantation, given their sterile and single-use nature?

  Since the Opus Pulse Generators are sterile and single-use, they must be stored in their original, unopened packaging in a clean, dry environment protected from contamination until immediately before use. The packaging ensures sterility is maintained, and any damaged or compromised packaging should be discarded to prevent infection risks during surgery.

• What is the intended clinical setting and user for the Opus Pulse Generators, and why is this important?

  These devices are intended for use in clinical settings by trained healthcare professionals, specifically during surgical implantation procedures. Their classification as life-supporting (Class III) underscores the need for expertise in cardiovascular care, as improper handling or implantation could compromise patient safety. The FDA 510(k) clearance and advisory committee review (CV) further emphasize their specialized use in regulated medical environments.