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Unilith 3 Models 7580/7583/7680/7683

by Ela Medical, Inc.

510(k) K883037

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 NumberK883037 Date25 Jan 1989ClearedStatusActive

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  • Withdrawn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
Models / Variants
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 3 Models 7580/7583/7680/7683 are implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are classified as Class 3 Cardiovascular implants under FDA product code DXY, adhering to regulatory standards for active implantable cardiac devices.

These pulse-generators are intended for surgical implantation and are regulated under the Traditional 510(k) pathway, receiving FDA clearance (K883037) in 1989. Supplied sterile and intended for single-use, they are manufactured by Ela Medical, Inc. and comply with regulation number 870.3610 for implantable pacemaker pulse-generators, ensuring adherence to cardiovascular device safety and performance requirements.

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