510(k) Report

FDA applicant

Electroscope, Inc.

Boulder, CO6 decisions1991–200012 recalls

FDA records 6 decisions for Electroscope, Inc. (Boulder, CO) from 1991 to 2000: 6 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 12 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 Electroscope, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electroscope, Inc. since 2007.

Recalls per year

6in 2011

2011: 6
2007high 6 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Electroscope, 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 & Accessories6decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K912780Monopolar Laparoscopic Electrodes W/EletroshieldElectroscope, Inc. · 19912cite it
  • K913625Electroscope Monitor, EM-1Electroscope, Inc. · 19911cites it

What has FDA decided for it lately?

  • K000480Active Electrode Monitoring SystemElectroscope, Inc. · 20003 recalls
  • K972562Bipolar Electrosurgical Pencil, Straight and AngledElectroscope, Inc. · 1998
  • K973682Bipolar Arthroscopic Probe, Straight, Biopolar Arthroscopic Probe, Angled, Bipolar Arthroscopic Probe…Electroscope, Inc. · 1997
  • K912780Monopolar Laparoscopic Electrodes W/EletroshieldElectroscope, Inc. · 19918 recalls
  • K912781ElectroshieldElectroscope, Inc. · 1991
  • K913625Electroscope Monitor, EM-1Electroscope, Inc. · 19911 recall

All 6 as Electroscope, Inc. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K912780ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder…Apr 7, 2011
  • K912780ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc.…Apr 7, 2011
  • K912780ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder…Apr 7, 2011
  • K912780ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc.…Apr 7, 2011
  • K912780ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301…Apr 7, 2011
  • K912780ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc.…Apr 7, 2011