Pan Set

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

510(k) Number

K813437 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Custom Sterile Procedure Kits

  Not classified

  FDA 510(k) K842356 Active Cleared 21 Mar 1985

• Sterile Design-Custom Sterile IV Kit

  Class II

  FDA 510(k) K842351 Active Cleared 15 Oct 1984

• Cardio Metric Custom Perfusion Tubing

  Class II

  FDA 510(k) K841959 Active Cleared 19 Oct 1984

• Custom Dressing Change Trays

  Class I

  FDA 510(k) K791738 Active Cleared 2 Oct 1979

• Cardio Metrics Cardiotomy Reservoir

  Class II

  FDA 510(k) K841958 Active Cleared 15 Oct 1984

• Graduated Guide Wire Bowl 8

  Class II

  FDA 510(k) K834237 Active Cleared 4 Feb 1984

See all devices from Sterile Design, Inc. →

• What is the PAN SET used for?

  The PAN SET is used to hold instruments, fluids, or other materials during clinical use in general hospital settings.

• Is the PAN SET supplied sterile?

  Yes, the PAN SET is supplied as a sterile, single-use device to ensure infection control and patient safety.

• How should the PAN SET be stored?

  The PAN SET should be stored and handled following standard sterile device protocols to maintain its sterility and effectiveness.