510(k) · Cleared
ClearedPKS Bill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Cleared on Dec 5, 2012 as substantially equivalent to K111059 (Gyrus Acmi, Inc., 2011) after a 100-day review. Its family tree reaches back 11 generations to 1994. 1 later device descends from it.
- Decided
- Dec 5, 2012
- Review
- 100 days
- Class
- Class II
- Product code
- HIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K936109 (1994). 80 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations between
- 3 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- 2 generations backK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- 1 generation backK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- This deviceK122605 PKS BillGyrus Acmi, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK142525 PK Lap LoopOlympus Winter & Ibe GmbH · 2014
Show all 11 generations
- Root · 11 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 10 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 9 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 8 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 7 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 6 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 5 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- 3 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- 2 generations backK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- 1 generation backK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- This deviceK122605 PKS BillGyrus Acmi, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K142525PK Lap LoopOlympus Winter & Ibe GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −10 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −8 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −7 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −6 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −5 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| −3 | K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and… | Gyrus Medical, Ltd. | 2004 | 2 |
| −2 | K050550 | Gyrus General Purpose Electrosurgical Generator | Gyrus Medical, Inc. | 2005 | — |
| −1 | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | Gyrus Acmi, Inc. | 2011 | — |
| 0 (this device) | K122605 | PKS Bill | Gyrus Acmi, Inc. | 2012 | — |
| +1 | K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 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 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 13 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 HIN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Summary page 1…Generic/Common Name: B iLap Loop / Bipolar Laparoscopic Loop Predicate Device Gyrus ACMI PKS Tm BiLL TM KI 111059 Indications for Use The PKS T M (Plasmakinetic System) BiLLTM (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrost… | 2011 |
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 |
|---|---|---|---|
| K142525 | PK Lap Loop | 2014 | 0 |
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 18 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 80 ancestors have a recall of any class.
- Of its descendants, K142525 (Olympus Winter & Ibe GmbH, 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K111059.
How does its category compare?
All HIN devicesHIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HIN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIN
Too few HIN 510(k)s in any year since 2007 to give a median.
Recalls per year · HIN
No recall names HIN since 2007.
Adverse event reports per year · HIN
43in 2025
MAUDE reports naming product code HIN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122605: PKS Bill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122605
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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