ELECTROSURGICAL PENCIL— 510(k) K936304

Clearance details

Applicant

E & M Engineering, Inc.

Product code

Code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

1993-12-20

Decision date

1994-06-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Richmond, VA, US

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• K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

• K984276 — DISPOSABLE ELECTROSURGERY GROUNDING PAD1999-02-10
• K952030 — LOOP/SQUARE ELECTRODE1996-07-31
• K945531 — BLADE ELECTRODE1995-02-10
• K936075 — REUSABLE, HAND CONTROLLED ESP1994-06-06
• K921271 — ELECTROSURGICAL UNIT1993-07-02

Death

133

Injury

7,585

Malfunction

35,808

Other

44

Total

43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1941-2018 — Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 Designed to hold active electrodes.Class II·Terminated·Olsen Medical·20180511
• Z-1990-2012 — Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.Class II·Terminated·PSC Industries Inc·20120605
• Z-1991-2012 — Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.Class II·Terminated·PSC Industries Inc·20120605

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K936304.