510(k) · Cleared
Recalled · Class II · 2026Gyrus Acmi Halo PKS Cutting Forceps
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 Jun 17, 2010 as substantially equivalent to K023492 (Gyrus Medical, Inc., 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 10 generations to 1994. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 17, 2010
- Review
- 78 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K936109 (1994). 72 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations between
- 3 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- 2 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- 1 generation backK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- This deviceK100896 Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK142759 PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK203277 Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK231777 Electrosurgical Generator ESG-410 and Accessories (WA91327U…Olympus Winter & Ibe GmbH · 2023 · Recalled
Show all 10 generations
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 9 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 8 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 7 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 6 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 5 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 4 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 3 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- 2 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- 1 generation backK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- This deviceK100896 Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K142759PK Cutting Forceps for ESG-400 WorkstationGyrus Acmi, Inc. · 2015 · cites it directly2descendants
- K203277Electrosurgical Generator ESG-410, Foot Switches, PK Cutting ForcepsOlympus Winter & Ibe GmbH · 2021 · 2 generations on1descendant
- K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories…Olympus Winter & Ibe GmbH · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −9 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −7 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −6 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −5 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −4 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −3 | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| −2 | K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and… | Gyrus Medical, Ltd. | 2004 | 2 |
| −1 | K050550 | Gyrus General Purpose Electrosurgical Generator | Gyrus Medical, Inc. | 2005 | — |
| 0 (this device) | K100896 | Gyrus Acmi Halo PKS Cutting Forceps | Gyrus Acmi, Inc. | 2010 | — |
| +1 | K142759 | PK Cutting Forceps for ESG-400 Workstation | Gyrus Acmi, Inc. | 2015 | — |
| +2 | K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | 2021 | 4 |
| +3 | K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W)… | Olympus Winter & Ibe GmbH | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 13 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K023492 | Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting ForcepsSummary page 1…Electrosurgical device for cutting and coagulation Predicate Device Gyrus Bipolar Cutting Forceps cleared under K023492 Gyrus General Surgery Generator cleared under K050550 Intended Uses The Gymus ACMI® HALO PKS Cutting Forceps is indicated for… | 2002 |
| * | K050550 | Gyrus General Purpose Electrosurgical GeneratorSummary page 1…coagulation Predicate Device Gyrus Bipolar Cutting Forceps cleared under K023492 Gyrus General Surgery Generator cleared under K050550 Intended Uses The Gymus ACMI® HALO PKS Cutting Forceps is indicated for electrosurgical coagulation, mechanical cutting and gr… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142759 | PK Cutting Forceps for ESG-400 Workstation | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2026 | Class II | Z-1641-2026 | Nonconforming Material/Component | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 72 ancestors have a recall of any class.
- Of its descendants, K142759 (Gyrus Acmi, Inc., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Gyrus AGMI® HALO PKS Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Cyrus ACMI General Surgery Generator (G400).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100896: Gyrus Acmi Halo PKS Cutting Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100896
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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