510(k) · Cleared
ClearedStryker Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 22, 2010 as substantially equivalent to K083162 (Stingray Surgical Products, Inc., 2009) and 2 other predicates after a 264-day review. Its family tree reaches back 6 generations to 1992. 10 later devices descend from it.
- Decided
- Jun 22, 2010
- Review
- 264 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K923332 (1992). 9 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 5 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 4 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 3 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 2 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- 1 generation backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- This deviceK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- Descendant · cites it directly · 3 of its ownK152219 PK AIMGyrus Acmi, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK163373 PK AIMGyrus Acmi, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K152219PK AIMGyrus Acmi, Inc. · 2015 · cites it directly3descendants
- K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · cites it directly3descendants
- K161825PK AIMGyrus Acmi, Inc. · 2016 · 2 generations on2descendants
- K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 2 generations on2descendants
- K163373PK AIMGyrus Acmi, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −5 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −4 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −3 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −2 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| −1 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| 0 (this device) | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| +1 | K152219 | PK AIM | Gyrus Acmi, Inc. | 2015 | — |
| +1 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| +2 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +2 | K121085 | Het Bipolar Ligator System | Het Systems, LLC | 2012 | — |
| +3 | K163373 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K083162 | Stingray Electrosurgical ForcepsSummary page 2…ded use, design, materials, and operational principles. The following devices are examples of predicate systems: * Bipolar Forceps (Stingray Surgical Products Inc., K083 162) * Bipolar Coagulation Forceps (Karl Storz, K960009) * Non-stick Bipolar Forceps (Silverglide Surgical Technologies,K19… | 2009 |
| * | K960009 | Storz S2050 Series Bipolar ForcepsSummary page 2…e following devices are examples of predicate systems: * Bipolar Forceps (Stingray Surgical Products Inc., K083 162) * Bipolar Coagulation Forceps (Karl Storz, K960009) * Non-stick Bipolar Forceps (Silverglide Surgical Technologies,K1992931)… | 1996 |
| * | K992931 | Non-Stick Bipolar ForcepsSummary page 2…Stingray Surgical Products Inc., K083 162) * Bipolar Coagulation Forceps (Karl Storz, K960009) * Non-stick Bipolar Forceps (Silverglide Surgical Technologies,K1992931) 6 4… | 1999 |
What descends from it? (10)
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 18 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K152219 (Gyrus Acmi, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K083162.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Stryker Bipolar Forceps are intended to be used during bipolar electrosurgery to grasp, manipulate and coagulate selected soft tissue. They are connected through a suitable bipolar cable to the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. The Stryker Bipolar Forceps have not been shown to be effective for tubal ligation or tubal cauterization for sterilization procedures and should not be used for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093108: Stryker Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093108
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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