510(k) Report

FDA applicant

E & M Engineering, Inc.

Richmond, VA6 decisions1993–19993 recalls

FDA records 6 decisions for E & M Engineering, Inc. (Richmond, VA) from 1993 to 1999: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HGI (Electrocautery, Gynecologic (And Accessories)). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided E & M Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for E & M Engineering, Inc. since 2007.

Recalls per year

1in 2018

2012: 22018: 1
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — E & M Engineering, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions
  • HGIElectrocautery, Gynecologic (And Accessories)1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K936304Electrosurgical PencilE & M Engineering, Inc. · 19943cite it
  • K936075Reusable, Hand Controlled EspE & M Engineering, Inc. · 19941cites it
  • K945531Blade ElectrodeE & M Engineering, Inc. · 19951cites it

What has FDA decided for it lately?

  • K984276Disposable Electrosurgery Grounding PadE & M Engineering, Inc. · 1999
  • K952030Loop/Square ElectrodeE & M Engineering, Inc. · 1996
  • K945531Blade ElectrodeE & M Engineering, Inc. · 1995
  • K936304Electrosurgical PencilE & M Engineering, Inc. · 19943 recalls
  • K936075Reusable, Hand Controlled EspE & M Engineering, Inc. · 1994
  • K921271Electrosurgical UnitE & M Engineering, Inc. · 1993

All 6 as E & M Engineering, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K936304Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF…May 11, 2018Class II
  • K936304Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use…Jun 5, 2012Class II
  • K936304Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device…Jun 5, 2012Class II