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Unilith 2 Pulse Generators #7550, 7552, 7760, 7762

by Ela Medical, Inc.

510(k) K852973

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 NumberK852973 Date31 Mar 1986ClearedStatusActive

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  • Withdrawn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 Unilith 2 Pulse Generators (#7550, 7552, 7760, 7762) are implantable pacemaker pulse-generators designed to deliver electrical impulses for cardiac rhythm regulation. These devices are classified under the FDA’s Implantable Pacemaker Pulse-Generator category and are intended for use in patients requiring cardiac pacing support.

These pulse generators are supplied sterile and intended for single-use implantation by qualified medical professionals. They are regulated under FDA 510(k) clearance (K852973) and fall under device classification DXY, with no third-party involvement. Storage and handling must comply with sterile medical device protocols to ensure device integrity prior to use.

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