510(k) Report

FDA applicant

Gyrus Medical, Inc.

Maple Grove, MN23 decisions1990–200519 recalls

FDA records 23 decisions for Gyrus Medical, Inc. (Maple Grove, MN) from 1990 to 2005: 23 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). Its devices cite 34 predicates, 10 of them its own earlier devices. 19 recalls are linked to its devices.

FDA’s records also spell it “Gyrus Medical , Ltd.”.

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 Gyrus Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gyrus Medical, Inc. since 2007.

Recalls per year

5in 2026

2008: 12009: 62010: 12013: 12014: 12024: 32026 (partial year): 5
2007high 6 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gyrus Medical, 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 & Accessories16decisions
  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)3decisions
  • HIHHysteroscope (And Accessories)2decisions
  • FJLResectoscope1decision
  • JRERefractometer For Clinical Use1decision

Whose devices does it build on?

Its devices cite 34 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 10 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.

  • K031085Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Gyrus Medical, Inc. · 20037cite it
  • K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 20055cite it
  • K990628Gyrus Endourology SystemGyrus Medical, Ltd. · 19994cite it
  • K024286Gyrus Open ForcepsGyrus Medical, Inc. · 20034cite it
  • K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)Gyrus Medical, Ltd. · 20043cite it
  • K031079Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeGyrus Medical, Inc. · 20033cite it

What has FDA decided for it lately?

  • K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
  • K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005
  • K041999Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc. · 2005
  • K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc. · 2004
  • K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)Gyrus Medical, Ltd. · 20042 recalls
  • K024286Gyrus Open ForcepsGyrus Medical, Inc. · 20036 recalls
  • K031085Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Gyrus Medical, Inc. · 2003
  • K031081Everest LP Bipolar Scissors and Gyrus LP Bipolar ScissorsGyrus Medical, Inc. · 20031 recall

All 15 as Gyrus Medical, Inc. →All 8 as Gyrus Medical, Ltd. →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K023492Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting…Feb 25, 2026Class II
  • K023492Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name…Feb 25, 2026Class II
  • K023492Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest…Feb 25, 2026Class II
  • K023492Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps…Feb 25, 2026Class II
  • K023492Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps…Feb 25, 2026Class II
  • K023492The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm…Jul 1, 2024Class II

Other applicant names beginning “Gyrus”

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

Gyrus Acmi, Inc. 46Gyrus Ent LLC 28