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Model 253-11 Cyberlith Pulse Generator

by Intermedics, Inc. 510(k)

Active United States

510(k) K800895

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800895 Date24 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  • Withdrawn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 Model 253-11 Cyberlith Pulse Generator is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is classified as a Class III medical device under FDA regulations, requiring pre-market approval due to its role in life-sustaining or supporting functions.

This device is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K800895) and falls under the Cardiovascular advisory committee classification. The pulse generator operates within the constraints of regulation number 870.3610, ensuring compliance with implantable pacemaker standards. Storage and handling must adhere to sterile medical device protocols.

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