Skip to content

Stanicor Gamma 333B/334A

by Cordis Corp.

510(k) K851416

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851416 Date11 Jun 1985ClearedStatusActive

Official records

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  • Withdrawn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 Stanicor Gamma 333B/334A is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is intended for patients requiring artificial pacing to correct bradycardia or other conduction disorders, ensuring consistent and reliable cardiac output.

This device is supplied as a reusable, implantable medical device and is classified under FDA regulation 870.3610. It is intended for use in clinical settings by trained healthcare professionals, adhering to sterile implantation procedures. The Stanicor Gamma 333B/334A holds an FDA 510(k) clearance (K851416) with a decision of Substantially Equivalent, granted in 1985, and is categorized under product code DXY.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →