Plastic Sterile Bags for Generators

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

Full name

Bags, Plastic, Sterile for Generators

510(k) Number

K780777 ↗

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 these sterile plastic bags for pacemaker pulse generators?

  These bags are designed to maintain the sterility and physical integrity of implantable pacemaker pulse generators during handling and storage before implantation. Their main function is to minimize contamination risks in the operating environment, ensuring the generator remains uncontaminated until use.

• Are these bags intended for reuse or single-use, and why?

  These bags are explicitly intended for single-use only. The manufacturer specifies they are disposable to preserve sterility and prevent cross-contamination between procedures, aligning with regulatory standards for Class III medical devices.

• How should these bags be stored to ensure sterility and usability?

  They must be stored in a clean, dry environment to protect sterility. The packaging is sterile upon receipt, and exposure to moisture or contaminants could compromise the integrity of the bag and the generator inside.

• Can these bags be used with MRI-compatible pacemaker generators?

  No, these bags are not intended for MRI use. The product description explicitly excludes MRI compatibility, so they should not be used in procedures involving MRI-compatible devices.

• What regulatory pathway was followed for FDA clearance of these bags?

  These bags received FDA 510(k) clearance (K780777) under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE) by the Cardiovascular (CV) Advisory Committee. The clearance was granted in 1978 and remains valid for use as sterile, disposable containers for pacemaker pulse generators.