510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

PKS Omni Instrument

K081766510(k) TraditionalCleared Aug 8, 200849-day reviewClass II21 CFR 878.4400Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gyrus-Acmi L.P. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 8, 2008 as substantially equivalent to K023493 (Gyrus Medical, Inc., 2002) and 5 other predicates after a 49-day review. Its family tree reaches back 10 generations to 1994. 3 later devices descend from it. It has been recalled once.

Decided
Aug 8, 2008
Review
49 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
6

Its longest line of descent runs back 10 generations to K936109 (1994). 87 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2003: 4 other ancestors2002: 3 other ancestors2001: 5 other ancestors2000: 14 other ancestors1998: 7 other ancestors1991: 4 other ancestors1996: 9 other ancestors1995: 11 other ancestors1994: 5 other ancestors1997: 4 other ancestors1992: 3 other ancestors1999: 1 other ancestor1980: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor2016: 2 descendants cleared2017: 1 descendant clearedK936109 · Sharplan Model 1120 CO2 Surgical Laser · Sharplan Lasers, Inc. · 1994K960521 · Sharplan Lasers, Inc. Silktouch Flash Scanner · Sharplan Lasers, Inc. · 1996K963339 · Coherent Ultrapulse CO2 Surgical Lasers · Coherent Medical Group · 1997K974789 · Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L · Lumenis, Inc. · 1998K990947 · Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and Delivery · Lumenis, Inc. · 1999K011703 · Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices · Lumenis · 2001 · recalled×2: 2 generations cleared close together, K014290 (2002), K021777 (2002) K041285 · Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes) · Gyrus Medical, Ltd. · 2004 · recalledK050460 · Gyrus Plasmacision and Plasmablend Electrodes · Gyrus Medical, Inc. · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 8 other ancestors3 generations back: 9 other ancestors4 generations back: 10 other ancestors5 generations back: 16 other ancestors6 generations back: 9 other ancestors7 generations back: 11 other ancestors8 generations back: 5 other ancestors9 generations back: 3 other ancestors10 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K050460 · Gyrus Plasmacision and Plasmablend Electrodes · Gyrus Medical, Inc. · 2005K041285 · Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes) · Gyrus Medical, Ltd. · 2004 · recalledK021777 · Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) · Gyrus Ent LLC · 2002K014290 · Entec Plasma Wands · Arthrocare Corp. · 2002K011703 · Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices · Lumenis · 2001 · recalledK990947 · Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and Delivery · Lumenis, Inc. · 1999K974789 · Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L · Lumenis, Inc. · 1998K963339 · Coherent Ultrapulse CO2 Surgical Lasers · Coherent Medical Group · 1997K960521 · Sharplan Lasers, Inc. Silktouch Flash Scanner · Sharplan Lasers, Inc. · 1996K936109 · Sharplan Model 1120 CO2 Surgical Laser · Sharplan Lasers, Inc. · 1994−10−50
  1. Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
  2. 6 generations between
  3. 3 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
  4. 2 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
  5. 1 generation backK050460 Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005
  6. This deviceK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008
  7. Descendant · cites it directly · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
  8. Descendant · 2 generations on · 1 of its ownK163373 PK AIMGyrus Acmi, Inc. · 2016
  9. Descendant · 3 generations on · 0 of its ownK170908 PK AIMGyrus Acmi, Inc. · 2017
Show all 10 generations
  1. Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
  2. 9 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
  3. 8 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
  4. 7 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
  5. 6 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
  6. 5 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
  7. 4 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
  8. 3 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
  9. 2 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
  10. 1 generation backK050460 Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc. · 2005
  11. This deviceK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K161825PK AIMGyrus Acmi, Inc. · 2016 · cites it directly2descendants
  • K163373PK AIMGyrus Acmi, Inc. · 2016 · 2 generations on1descendant
  • K170908PK AIMGyrus Acmi, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K936109Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc.1994—
−9K960521Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc.1996—
−8K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997—
−7K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc.1998—
−6K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…Lumenis, Inc.1999—
−5K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis20012
−4K014290Entec Plasma WandsArthrocare Corp.2002—
−3K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC2002—
−2K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd.20042
−1K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.2005—
0 (this device)K081766PKS Omni InstrumentGyrus-Acmi L.P.2008—
+1K161825PK AIMGyrus Acmi, Inc.2016—
+2K163373PK AIMGyrus Acmi, Inc.2016—
+3K170908PK AIMGyrus Acmi, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198610
198910
199010
199140
199230
199310
199450
1995110
199690
199740
199870
199910
2000140
200150
200230
200340
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201710
FIG. 1 — Lineage of K081766, 1994–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K023493PK Zip Wing Cutting Dissector
Summary page 1
…trument Generic/Common Name: Electrosurgical Instruments Predicate Device Gyrms Medical Inc. Zip Wing Cutting Dissector K023493 Gyrms Medical Open Forceps K024286 Gyms Medical Plasma Seal…
Gyrus Medical, Inc.2002—
*K024286Gyrus Open Forceps
Summary page 1
…Instruments Predicate Device Gyrms Medical Inc. Zip Wing Cutting Dissector K023493 Gyrms Medical Open Forceps K024286 Gyms Medical Plasma Seal K061975 Gyrms Medical Plasmacision and Plasmablend Electrodes…
Gyrus Medical, Inc.20036
*K061975Plasmaseal Open Forceps, Models 2103PK and 91701PK
Summary page 1
…ctor K023493 Gyrms Medical Open Forceps K024286 Gyms Medical Plasma Seal K061975 Gyrms Medical Plasmacision and Plasmablend Electrodes K050460 Valleylab Ligasure Sealing System/ Ligasure V…
Acmi Corporation2006—
*K050460Gyrus Plasmacision and Plasmablend Electrodes
Summary page 1
…K024286 Gyms Medical Plasma Seal K061975 Gyrms Medical Plasmacision and Plasmablend Electrodes K050460 Valleylab Ligasure Sealing System/ Ligasure V K031011 Gyms General Purpose Electrosurgical Generator…
Gyrus Medical, Inc.2005—
*K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500
Summary page 1
…K061975 Gyrms Medical Plasmacision and Plasmablend Electrodes K050460 Valleylab Ligasure Sealing System/ Ligasure V K031011 Gyms General Purpose Electrosurgical Generator K050550 Intended Uses The Gyrms ACMI Inc.PKS Omni Instrument i…
Valleylab, Inc.20032
*K050550Gyrus General Purpose Electrosurgical Generator
Summary page 1
…d Electrodes K050460 Valleylab Ligasure Sealing System/ Ligasure V K031011 Gyms General Purpose Electrosurgical Generator K050550 Intended Uses The Gyrms ACMI Inc.PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping and disse…
Gyrus Medical, Inc.2005—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161825PK AIMGyrus Acmi, Inc.20162

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 9, 2021Class IIZ-2380-2021Process controlExpired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
  • 7 of the 87 ancestors have a recall of any class.
  • Of its descendants, K161825 (Gyrus Acmi, Inc., 2016) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Gyms ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation,

mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the

performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyms ACMI G400 workstation.

Indications for use as stated in the FDA summary.

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K081766 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081766: PKS Omni Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081766

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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