510(k) Report

FDA applicant

Aspen Labs

Englewood, CO6 decisions1991–19971 recall

FDA records 6 decisions for Aspen Labs (Englewood, CO) from 1991 to 1997: 6 510(k) clearances. Most are in product codes HGI (Electrocautery, Gynecologic (And Accessories)) and GEI (Electrosurgical, Cutting & Coagulation &…). 1 recall is linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Aspen Labs’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aspen Labs since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aspen Labs 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?

  • HGIElectrocautery, Gynecologic (And Accessories)2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • HFGCoagulator, Laparoscopic, Unipolar (And Accessories)1decision
  • DWGElectrosurgical Device1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K905654Electrosurgical Unit with AccessoriesAspen Labs · 19911cites it
  • K970493Hyfrecator 2000Aspen Labs · 19971cites it

What has FDA decided for it lately?

  • K970493Hyfrecator 2000Aspen Labs · 19971 recall
  • K925333Single Use Tungsten Wire Lee Loop ElectrodeAspen Labs · 1994
  • K931215Hand-Trol SAspen Labs · 1994
  • K912046Single Use Lee ElectrodeAspen Labs · 1992
  • K905654Electrosurgical Unit with AccessoriesAspen Labs · 1991
  • K904240Single Use Laparscopic ElectrodeAspen Labs · 1991

All 6 as Aspen Labs →

What has been recalled?

1 recall linked to its devices; the latest:

  • K970493Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may…Sep 15, 2003

Other applicant names beginning “Aspen”

FDA records each applicant name separately; these may or may not be the same firm.

Aspen Laboratories, Inc. 55Aspen Glove Sdn. Bhd. 4Aspen Surgical Products, Inc. 2Aspen Laser Systems, LLC 2Aspen Imaging Healthcare, Inc. 2Aspen Medical, Ltd. 1