510(k) · Cleared
Recalled · Class II · 2019Olympus Energy Power System (Eps)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 5, 2013 as substantially equivalent to K034004 (Gyrus Ent LLC, 2004) and 4 other predicates after a 149-day review. Its family tree reaches back 14 generations to 1994. 1 later device descends from it. It has been recalled 12 times.
- Decided
- Apr 5, 2013
- Review
- 149 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 12
- Predicates
- 5
Its longest line of descent runs back 14 generations to K936109 (1994). 96 ancestors in all, the oldest K780977 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations between
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- 1 generation backK121678 DTADGyrus Acmi, Inc. · 2012
- This deviceK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
Show all 14 generations
- Root · 14 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 13 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 12 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 11 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 10 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 9 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 8 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 6 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 5 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 4 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 3 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 2 generations backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- 1 generation backK121678 DTADGyrus Acmi, Inc. · 2012
- This deviceK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −13 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −11 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −10 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −9 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −8 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −6 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −5 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −4 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −3 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −2 | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | 2009 | — |
| −1 | K121678 | DTAD | Gyrus Acmi, Inc. | 2012 | — |
| 0 (this device) | K123429 | Olympus Energy Power System (Eps) | Gyrus Acmi, Inc. | 2013 | — |
| +1 | K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 12 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K034004 | Diego RF Powered Dissector and Drill System ConsoleSummary page 2…, Burs, Instrument Tray Predicate Devices Gyrus AGMI Diego® RE Powered Dissector & Drill System: K034004 Cyrus ACMI Diego® Starlink with IGS K030343 Covidien ValleyLab Force EX… | 2004 |
| * | K030343 | Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting InterfaceSummary page 2…Gyrus AGMI Diego® RE Powered Dissector & Drill System: K034004 Cyrus ACMI Diego® Starlink with IGS K030343 Covidien ValleyLab Force EX K944602 Cyrus AGMI DTAD… | 2003 |
| * | K944602 | Valleylab Force FXSummary page 2…4 Cyrus ACMI Diego® Starlink with IGS K030343 Covidien ValleyLab Force EX K944602 Cyrus AGMI DTAD K 121678. Olympus KV-5 Powered Suction Pump… | 1995 |
| * | K121678 | DTADSummary page 2…3 Covidien ValleyLab Force EX K944602 Cyrus AGMI DTAD K 121678. Olympus KV-5 Powered Suction Pump K0l11725 Product Description The DIEGO ELITE s… | 2012 |
| * | K011725 | Olympus Suction Pump, Model KV-5 | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212650 | Celeris, Disposable Sinus Debrider | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2019 | Class II | Z-1184-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1178-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1180-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1187-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1181-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1185-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1186-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1183-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1182-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| Mar 8, 2019 | Class II | Z-1179-2019 | Software design | Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades |
| May 8, 2015 | Class II | Z-1753-2015 | Under Investigation by firm | Potential lack of sterility assurance. |
| May 8, 2015 | Class II | Z-1752-2015 | Under Investigation by firm | Potential lack of sterility assurance. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 96 ancestors have a recall of any class.
- Of its descendants, K212650 (Gyrus Acmi, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K034004.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and bard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal/ Laryngology, and Head & Neck procedures. Specific procedures and applications would include: Sinus / Rhinology: * FESS (Functional Endoscopic Sinus Surgery) o Including Endoscopic approaches to: Polypectomy…
Read the full statement (127 words)
The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and bard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal/ Laryngology, and Head & Neck procedures.
Specific procedures and applications would include:
Sinus / Rhinology:
* FESS (Functional Endoscopic Sinus Surgery)
o Including Endoscopic approaches to: Polypectomy, Ethmnoidectomly, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
* Septal Spur removal
* Endoscopic DCR
* Trans-sphenoidal procedures specifically to create access through the sinuses to the Pituitary, Skull base, and CSF leak repair
* Turbinate Reduction / Turbinoplasty
oi Including sub mucosal resection
Nasopharyngeal / Laryngeal:
* Adenoidectomy / Tonsillectomy
* Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, Polypectomy
Head & Neck:
*Soft tissue shaving
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123429: Olympus Energy Power System (Eps).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123429
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026