510(k) · Cleared
Recalled · 2009Gyrus Open Forceps
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 Nov 17, 2003 as substantially equivalent to K000496 (Everest Medical Corp., 2000) and 2 other predicates after a 329-day review. Its family tree reaches back 2 generations to 1994. 14 later devices descend from it. It has been recalled 6 times.
- Decided
- Nov 17, 2003
- Review
- 329 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 2 generations to K932293 (1994). 9 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 1 generation backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- This deviceK024286 Gyrus Open ForcepsGyrus Medical, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK061975 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008 · cites it directly7descendants
- K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · 2 generations on6descendants
- K061975Plasmaseal Open Forceps, Models 2103PK and 91701PKAcmi Corporation · 2006 · cites it directly4descendants
- K081766PKS Omni InstrumentGyrus-Acmi L.P. · 2008 · cites it directly3descendants
- K161825PK AIMGyrus Acmi, Inc. · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −1 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| 0 (this device) | K024286 | Gyrus Open Forceps | Gyrus Medical, Inc. | 2003 | — |
| +1 | K081503 | Aed Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | 2008 | — |
| +2 | K103508 | Unmiax Laparoscopic Instrument | Unimax Medical Systems, Inc. | 2011 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K000496 | Evershears Bipolar ScissorsSummary page 1…Proprietary Name: Gyrus OPEN FORCEPS The device is a Class I1 medical device. The Gyrus OPEN FORCEPS is a modification to the predicate device cleared under K000496. The Open Forceps is similar in construction and in component materials when compared to the predicate device. The indications fo… | 2000 |
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…s is similar in construction and in component materials when compared to the predicate device. The indications for use are similar to the predicate devices cleared under K98 1916 and K010010. The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow… | 1998 |
| * | K010010 | Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure…Summary page 1…in construction and in component materials when compared to the predicate device. The indications for use are similar to the predicate devices cleared under K98 1916 and K010010. The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physicia… | 2001 |
What descends from it? (14)
See all 144 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2009 | Not classified | Z-0632-2010 | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field.… |
| Aug 18, 2009 | Not classified | Z-0633-2010 | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field.… |
| Aug 18, 2009 | Not classified | Z-0634-2010 | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field.… |
| Aug 18, 2009 | Not classified | Z-0635-2010 | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field.… |
| Aug 18, 2009 | Not classified | Z-0637-2010 | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field.… |
| Aug 18, 2009 | Not classified | Z-0636-2010 | Environmental control | Gyrus ACMI received complaints of a problem with 3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK - Gyrus ACMI PKS Seal Open Forceps. The metal shim between the jaws may detach during the procedure and fall into the surgical field.… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K081503 (National Advanced Endoscopy Devices, Inc., 2008) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K000496.
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?
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/K024286 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024286: Gyrus Open Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024286
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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