510(k) · Cleared
ClearedGyrus Plasmacision Laparoscopic Spatula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 22, 2004 as substantially equivalent to K031079 (Gyrus Medical, Inc., 2003) and 2 other predicates after a 128-day review. Its family tree reaches back 8 generations to 1994. 8 later devices descend from it.
- Decided
- Oct 22, 2004
- Review
- 128 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K936109 (1994). 67 ancestors in all, the oldest K800617 (1980). 8 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 2 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 1 generation backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- This deviceK041633 Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK142289 PK SpatulaGyrus Acmi, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK122605 PKS BillGyrus Acmi, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK080093 PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK213831 Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK…Gyrus Acmi, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · cites it directly3descendants
- K142289PK SpatulaGyrus Acmi, Inc. · 2014 · cites it directly1descendant
- K122605PKS BillGyrus Acmi, Inc. · 2012 · 2 generations on1descendant
- K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc. · 2008 · cites it directly1descendant
- K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −2 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −1 | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| 0 (this device) | K041633 | Gyrus Plasmacision Laparoscopic Spatula | Gyrus Medical, Inc. | 2004 | — |
| +1 | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | Gyrus Acmi, Inc. | 2011 | — |
| +1 | K142289 | PK Spatula | Gyrus Acmi, Inc. | 2014 | — |
| +2 | K122605 | PKS Bill | Gyrus Acmi, Inc. | 2012 | — |
| +1 | K080093 | PKS Plasma Morcellator, Models 962000PK, 3620PK | Gyrus Acmi, Inc. | 2008 | — |
| +2 | K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle | Gyrus Acmi, Inc. | 2022 | — |
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 | 10 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K031079 | Everest Bipolar Needle Electrode & Gyrus Bipolar Needle ElectrodeSummary page 1…Accessories (per 21 CFR 878.4400) Brand Name: Not yet assigned Predicate Devices: Gymus PK Bipolar Needle Electrode K031079 Gyrus PK Bipolar L Hook Electrode K031082 Gymu… | 2003 |
| * | K031082 | Everest Bipolar L Hook & PK Bipolar L HookSummary page 1…Predicate Devices: Gymus PK Bipolar Needle Electrode K031079 Gyrus PK Bipolar L Hook Electrode K031082 Gymus PlasmaCision Scimitar Instrument K021777 Description: The Gyrus PlasmaCi… | 2003 |
| * | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Summary page 1…Gyrus PK Bipolar L Hook Electrode K031082 Gymus PlasmaCision Scimitar Instrument K021777 Description: The Gyrus PlasmaCision Laparoscopic Spatula is a bipolar electrosurgical instrument with the capability… | 2002 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 67 ancestors have a recall of any class.
- Of its descendants, K111059 (Gyrus Acmi, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K031079.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PlasmaCision Laparoscopic Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Gyrus PlasmaKinetic Generator or the Gyrus PlasmaKinetic SuperPulse Generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041633 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041633: Gyrus Plasmacision Laparoscopic Spatula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041633
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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