Cyberlith IX Implantable Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K801337 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

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  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the Cyberlith IX Implantable Pulse Generator used for in clinical practice?

  The Cyberlith IX Implantable Pulse Generator is designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients who require temporary or permanent pacing support due to bradycardia (slow heart rate) or other conduction disorders, ensuring consistent and controlled heartbeats.

• Is the Cyberlith IX Implantable Pulse Generator intended for single-use or reusable applications?

  The Cyberlith IX Implantable Pulse Generator is explicitly designed for single-use within the body after surgical implantation. It is not intended for reuse or external applications, as it is meant to remain implanted subcutaneously as a permanent or temporary pacing solution.

• How is the Cyberlith IX Implantable Pulse Generator supplied, and what are the handling requirements?

  The device is supplied sterile and requires surgical implantation by a qualified healthcare professional in a controlled clinical setting. Since it is implanted subcutaneously, it must be handled under sterile conditions to prevent infection and ensure proper functionality.

• What regulatory pathway was followed for the Cyberlith IX Implantable Pulse Generator’s approval?

  The Cyberlith IX Implantable Pulse Generator was cleared through the FDA 510(k) process (K801337) under the classification of an Implantable Pacemaker Pulse-Generator (DXY). It was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to prior devices, with a traditional clearance type.