Malis Bipolar Cord/Irrigation Tubing Set

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

510(k) Number

K890648 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Valley Forge Bipolar Pen or Forceps

  Class II

  FDA 510(k) K910510 Active Cleared 22 Apr 1991

• Vally Forge Scientific Malis Bipolar Disposable Finger Operated Electrosurgical Instruments

  Class II

  FDA 510(k) K042604 Active Cleared 22 Oct 2004

• Bi-Tech I Bipolar Coagulator/Cutting System

  Class II

  FDA 510(k) K924188 Active Cleared 10 Dec 1992

• Valley Forge Scien-Tens Unit & Access. Lead Wire &

  Class II

  FDA 510(k) K853992 Active Cleared 21 Feb 1986

• Malis Surgical Loupes

  Class I

  FDA 510(k) K874845 Active Cleared 23 Dec 1987

• Malis 2000 Bipolar Electrosurgical System

  Class II

  FDA 510(k) K050364 Active Cleared 9 Mar 2005

See all devices from Valley Forge Scientific Corp. →

• What types of surgical procedures is this tubing set designed to assist with, and why is the irrigation feature important in those contexts?

  The Malis Bipolar Cord/Irrigation Tubing Set is specifically designed for bipolar electrosurgery procedures, including micro, macro, and endoscopic surgeries. The irrigation feature is critical in these contexts because it helps maintain a clear surgical field by flushing away smoke, debris, and blood—common byproducts of electrosurgery—while also cooling the tissue, reducing thermal damage and improving visibility for the surgeon.

• Is this tubing set reusable, or is it intended for single-use only? What does that mean for surgical workflows?

  This tubing set is explicitly intended for single-use only, as stated in the manufacturer’s description. This means it should not be cleaned, reprocessed, or reused between patients, which helps ensure sterility and reduces the risk of cross-contamination. For surgical workflows, this implies each set must be opened and used once per procedure, requiring proper inventory management to maintain availability.

• How is the tubing set supplied, and what should clinicians check before using it in the operating room?

  The Malis Bipolar Cord/Irrigation Tubing Set is supplied sterile in its packaging, ready for immediate use in surgical environments. Clinicians should verify the sterility indicator (if present) and ensure the packaging remains unopened and intact before use. Additionally, since it is designed for bipolar electrosurgery, compatibility with the specific bipolar system being used should be confirmed to avoid malfunctions.

• What sizes or models are available for this tubing set, and how might that affect its application in different surgical procedures?

  The provided specifications do not explicitly list distinct sizes or models, but the tubing set is described as suitable for micro, macro, and endoscopic applications. This suggests flexibility in use across different surgical scales. Clinicians should confirm with the manufacturer if specific length or diameter variations are available to match their procedure requirements, as this could impact precision and ease of use in tight or confined surgical spaces.

• Can this tubing set be used in an MRI environment, and if not, what precautions should be taken during surgery?

  The Malis Bipolar Cord/Irrigation Tubing Set is not MRI-compatible, meaning it should not be used in or near MRI machines. During surgery, clinicians must ensure the device remains outside the MRI zone to avoid interference with imaging or potential damage to the equipment. If MRI imaging is required during the procedure, the tubing set should be removed or positioned away from the MRI field.