510(k) · Cleared
ClearedPlasmaseal Open Forceps, Models 2103PK and 91701PK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 10, 2006 as substantially equivalent to K024286 (Gyrus Medical, Inc., 2003) after a 28-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Aug 10, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932293 (1994). 10 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 2 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 1 generation backK024286 Gyrus Open ForcepsGyrus Medical, Inc. · 2003 · Recalled
- This deviceK061975 Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation · 2006
- Descendant · cites it directly · 3 of its ownK081766 PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK163373 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK170908 PK AIMGyrus Acmi, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −2 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −1 | K024286 | Gyrus Open Forceps | Gyrus Medical, Inc. | 2003 | 6 |
| 0 (this device) | K061975 | Plasmaseal Open Forceps, Models 2103PK and 91701PK | Acmi Corporation | 2006 | — |
| +1 | K081766 | PKS Omni Instrument | Gyrus-Acmi L.P. | 2008 | 1 |
| +2 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +3 | K163373 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +4 | K170908 | PK AIM | Gyrus Acmi, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K024286 | Gyrus Open ForcepsSummary page 1…Gyrus Medical Open Forceps Generic/Common Name: Electrosurgical Instruments Predicate Device Gyrus Medical Open Forceps K024286 Intended Uses The Gyrus Medical Inc. Open Forceps are intended for electrosurgical coagulation, mechanical grasping and dissect… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081766 | PKS Omni Instrument | 2008 | 3 |
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 12 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K081766 (Gyrus-Acmi L.P., 2008) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K024286.
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 Medical Inc. Open Forceps are intended for electrosurgical coagulation,
mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during
the performance of open general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061975: Plasmaseal Open Forceps, Models 2103PK and 91701PK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061975
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