Generator, 16 Series, Modified Top Cap

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K790868 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary purpose of the Generator, 16 Series, Modified Top Cap, and how does it function in a patient’s body?

  This device is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders. It delivers controlled electrical pacing impulses to the heart via implanted leads, ensuring consistent and reliable cardiac function over the long term. It is intended for surgical implantation by trained healthcare professionals in clinical settings.

• Is this device intended for single-use or can it be reused? How does this affect its handling and storage?

  The Generator, 16 Series, Modified Top Cap is reusable, meaning it is not intended for single-use. Since it is non-sterile, it must be properly cleaned and sterilized between uses in a clinical setting. Storage should follow manufacturer guidelines to maintain device integrity, though no specific sterility or storage requirements are detailed in the provided data.

• What regulatory pathway was followed for this device’s approval, and what does that mean for its use?

  This device was cleared via the FDA 510(k) pathway (K790868), specifically under the Traditional review process with a substantially equivalent determination. It falls under the Cardiovascular advisory committee (CV) and is classified as a Class III Implantable Pacemaker Pulse-Generator (DXY). This means it is regulated for safety and efficacy, but its use remains restricted to clinical settings by qualified personnel as per the provided data.

• Are there any known limitations or special handling requirements for this device, such as MRI compatibility?

  The provided data does not specify MRI safety requirements for this device, meaning its compatibility with MRI procedures is not addressed. Clinicians should follow manufacturer guidelines or consult the device’s documentation to determine safe handling, especially in environments with magnetic fields. As an implantable device, standard precautions for surgical implantation apply.