Unilith Pulse Generator

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

Full name

Ela Medical Unilith Pulse Generator

510(k) Number

K810142 ↗

FDA Product Code

DXY

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

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• 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

See all devices from Ela Medical, Inc. →

• What is the primary purpose of the Unilith Pulse Generator and which patients would benefit from it?

  The Unilith Pulse Generator is designed to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders by delivering consistent electrical pacing signals. It is intended for implantation in patients who require chronic pacing support to maintain proper cardiac function.

• Is the Unilith Pulse Generator intended for reuse or is it meant to be implanted as a single-use device?

  The Unilith Pulse Generator is explicitly intended for single-use implantation only. It is supplied sterile and meant to be implanted by qualified healthcare professionals during surgery, with no provision for reuse.

• How is the Unilith Pulse Generator regulated in the U.S., and what does that mean for clinicians or buyers?

  The Unilith Pulse Generator is regulated under the FDA’s 510(k) clearance (K810142) as a Class III medical device, classified under the product code DXY for implantable pacemaker pulse generators. This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for its intended use in treating bradycardia or conduction disorders.

• What should clinicians consider regarding storage and handling of the Unilith Pulse Generator before implantation?

  The Unilith Pulse Generator is supplied sterile, so clinicians must follow sterile handling protocols during preparation for implantation. It should be stored in its original packaging until use, protected from contamination or physical damage, as it is intended for direct surgical implantation without reprocessing.