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Cyberlith Implantable Pulse Gen. #253-02

by Intermedics, Inc. 510(k)

Active United States

510(k) K800644

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800644 Date16 Apr 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 Implantable Pulse Generator #253-02 is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It falls under the classification of a Class III medical device, requiring stringent regulatory oversight due to its role in life-sustaining or life-supporting functions.

This device is intended for surgical implantation within the body and is supplied sterile for single-use. It is classified as MRI Conditional, allowing for specific MRI procedures under controlled conditions. The device is authorized under an FDA 510(k) clearance with a decision code of SESE (Substantially Equivalent). It is regulated under the regulation number 870.3610 and is associated with the product code DXY.

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