Model 50 Bipolar Coagulator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K972350 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Electrosurgical Endoscopic Cord

  Class II

  FDA 510(k) K945717 Active Cleared 8 Dec 1994

• Electrosurgical Cutting & Coagulation Device & Accessories

  Class II

  FDA 510(k) K944642 Active Cleared 8 Dec 1994

• Bipolar Electrosurgical Pencil

  Class II

  FDA 510(k) K943031 Active Cleared 23 Sep 1994

• Disposable & Reusable Surgical Cutting Tools

  Class I

  FDA 510(k) K953012 Active Cleared 12 Jul 1995

• Disposable & Resuable Irrigation/Aspiration Handpiece

  Class I

  FDA 510(k) K945171 Active Cleared 8 Feb 1995

• Disposable & Reusable Monopolar Electrosurigical Electrode

  Class II

  FDA 510(k) K945893 Active Cleared 13 Dec 1994

See all devices from Boston Surgical Products, Inc. →

• What is the primary function of the Model 50 Bipolar Coagulator?

  The Model 50 Bipolar Coagulator is a solid state bipolar generator engineered to provide an RF signal to electrosurgical handpieces. It is specifically designed for the coagulation of soft body tissues during surgical procedures.

• In which clinical settings is this device intended to be used?

  This device is intended for use in general and plastic surgery applications. It is designed to operate effectively across a wide range of tissue types, patient conditions, and load impedances.

• What is the regulatory status of the Model 50 Bipolar Coagulator?

  The Model 50 Bipolar Coagulator is authorized under FDA 510(k) clearance K972350. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.