510(k) K123429 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
OLYMPUS ENERGY POWER SYSTEM (EPS)
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Apr 5, 2013 |
| Received | Nov 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2019 | Gyrus ACMI, Inc. Olympus Diego Elite Console
MDCONS 100 Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A
Part No BB2000SA Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm straight,
Part Number: BB4000SS Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm straight,
Part No: BB4000SC Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number:BB4040SS Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number: BB4040SC Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Turbinate Blades Bipolar Blade, 4mm curved,
Product Number: BB4040XC Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Blades Monopolar, 4mm Straight, TIA
Product Code:MB4000SS Terminated |
GEI | None listed |
| Mar 8, 2019 | Gyrus ACMI, Inc. Diego Elite Malleable, 4mm Standard Monopolar Blades
Product Code:MM4000SS Terminated |
GEI | None listed |
| Jun 11, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and H Terminated |
GEI | None listed |
| Jun 11, 2015 | Gyrus Acmi, Incorporated Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and H Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.