Model E2517 and Model E2503 Power Control Pencils

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K861112 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Models E2502B/E2525 Reusable Handswitching Pencils

  Class II

  FDA 510(k) K914400 Active Cleared 17 Oct 1991

• Cusa System 200C, T & M Ultrasonic Surgical Aspira.

  Unclassified

  FDA 510(k) K884412 Active Cleared 2 Dec 1988

• Valleylab Procision(Tm) System

  Class II

  FDA 510(k) K945688 Active Cleared 13 Jun 1995

• Ligasure 5mm Blunt Tip Laparoscopic Sealer-Divider

  Class II

  FDA 510(k) K092879 Active Cleared 16 Oct 2009

• Davis Bayonet Electrodes

  Class II

  FDA 510(k) K964602 Active Cleared 9 Jan 1997

• Force Gsu System Model No. Gsu-20 and Gsu-22

  Class II

  FDA 510(k) K942579 Active Cleared 21 Sep 1994

See all devices from Valleylab, Inc. →

• What clinical purpose do the Model E2517 and E2503 Power Control Pencils serve?

  They are electrosurgical cutting and coagulation accessories that deliver high‑frequency electrical current to remove tissue and control bleeding, enabling precise power modulation during surgical procedures.

• How are the power control pencils supplied to the user?

  Each pencil is supplied as an individual unit, ready for use in the operating room, which simplifies inventory management and ensures that a single, sterile device is available for each case.

• Are the Model E2517 and E2503 pencils intended for single‑use or reuse?

  They are provided as individual units for use in a procedure and are not designed for repeated sterilization, so they are effectively single‑use accessories.

• What models are available and how do they differ?

  Two models are listed: E2517 and E2503. Both function as power control pencils for electrosurgical instruments, but they are distinguished by their model numbers, allowing clinicians to select the specific version referenced in their surgical protocols.

• What regulatory clearance applies to these devices?

  The pencils received traditional FDA 510(k) clearance (K861112) with product code GEI, indicating they were found substantially equivalent to a legally marketed predicate device.