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Cyberlith Programmer

by Intermedics, Inc.

510(k) K801338

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)SESE Substantially Equivalent · Traditional NumberK801338 Date7 Jan 1981ClearedStatusActive

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  • Withdrawn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
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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 Cyberlith Programmer is an Implantable Pacemaker Pulse-Generator, designed to program and adjust the electrical output of implanted cardiac pacemakers. It facilitates precise control over pacing parameters, such as heart rate and timing, to ensure proper cardiac function in patients with arrhythmias or conduction disorders.

This device is intended for use in clinical settings by trained healthcare professionals, typically in cardiac electrophysiology labs or operating rooms. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accuracy and safety. The Cyberlith Programmer holds FDA 510(k) clearance under classification DXY and is regulated under 21 CFR 870.3610 for implantable pacemaker systems.

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