510(k) · Cleared
Recalled · Class II · 2012Stingray Electrosurgical Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stingray Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 12, 2009 as substantially equivalent to K070997 (Pro-Med Instruments GmbH, 2007) after a 77-day review. Its family tree reaches back 5 generations to 1992. 13 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K923332 (1992). 7 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 4 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 3 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 2 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 1 generation backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- This deviceK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- Descendant · 2 generations on · 3 of its ownK152219 PK AIMGyrus Acmi, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- Descendant · 3 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K093108Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010 · cites it directly10descendants
- K152219PK AIMGyrus Acmi, Inc. · 2015 · 2 generations on3descendants
- K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · 2 generations on3descendants
- K161825PK AIMGyrus Acmi, Inc. · 2016 · 3 generations on2descendants
- K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −4 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −3 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −2 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −1 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| 0 (this device) | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | — |
| +1 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| +2 | K152219 | PK AIM | Gyrus Acmi, Inc. | 2015 | — |
| +2 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| +3 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
| +3 | K121085 | Het Bipolar Ligator System | Het Systems, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables…Summary page 1…sories Product Codes Product Code GEI Common/Usual Name: Bipolar Forceps . Equivalent legally marketed devices: ProMed Instruments GmbH DORO® Non-Stick Bipolar Forceps K070997 . Indications for Use (intended use) Designed to grasp, manipulate and coagulate selected tissue for use in general surgical pro… | 2007 |
What descends from it? (13)
See all 133 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 |
|---|---|---|---|---|
| May 23, 2012 | Class II | Z-2011-2012 | Packaging | On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K093108 (Stryker Leibinger GmbH & Co KG, 2010) has gone furthest, with 10 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K083162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083162: Stingray Electrosurgical Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083162
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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