510(k) · Cleared
ClearedStingray Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stingray Surgical Products · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 10, 2013 as substantially equivalent to K083162 (Stingray Surgical Products, Inc., 2009) after a 178-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- May 10, 2013
- Review
- 178 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K923332 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK123478 Stingray Bipolar ForcepsStingray Surgical Products · 2013
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) | K123478 | Stingray Bipolar Forceps | Stingray Surgical Products | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K083162 | Stingray Electrosurgical ForcepsSummary page 2…Predicate Device Information Labeling and Intended Use Device Description and Comparison The predicate device is the Stingray Electrosurgical Forceps [K083162, concurrence date 01/12/2009). Useful Life: The lifetime of the device has been best estimated based on the average age of devic… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 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. 2013, 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 electrosurgical 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/K123478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123478: Stingray Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123478
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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