Bipolar Electrosurgical Pencil

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K943031 ↗

FDA Product Code

HQO

Device Class

Class II

Regulation

21 CFR Part 886.4115

Advisory Committee

Ophthalmic

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

• 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

• Disoposable & Resuable Monpolar Cord

  Class II

  FDA 510(k) K951912 Active Cleared 12 May 1995

See all devices from Boston Surgical Products, Inc. →