510(k) · Cleared
ClearedHet Bipolar Electrocautery Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Het Systems, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 2, 2011 as substantially equivalent to K926414 (Valleylab, Inc., 1993) and 4 other predicates after a 135-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Jun 2, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K923332 (1992). 24 ancestors in all, the oldest K904646 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 6 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 5 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 4 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 3 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- 2 generations backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- 1 generation backK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- This deviceK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- Descendant · cites it directly · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
- Descendant · 2 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020
Most influential descendants
Showing 3 of 3 · See all- K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · cites it directly2descendants
- K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014 · 2 generations on1descendant
- K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −6 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −5 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −4 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −3 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| −2 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| −1 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| 0 (this device) | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| +1 | K121085 | Het Bipolar Ligator System | Het Systems, LLC | 2012 | — |
| +2 | K140422 | Het Systems, LLC, Het Bipolar Ligator System | Het Systems, LLC | 2014 | — |
| +3 | K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | Covidien, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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? (5)
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 |
|---|---|---|---|
| * | K926414 | Valleylab Macrobipolar Forceps Handpiece, E3200Summary page 1…21 CFR 878.4400 Predicate Devices Valleylab, Inc. (now Covidien) Valleylab Bipolar Forceps 510O(k) K926414 Link Technology, Inc. (subsequently Silverglide Surgical Technologies currently Stryker)… | 1993 |
| * | K992931 | Non-Stick Bipolar ForcepsSummary page 1…k Technology, Inc. (subsequently Silverglide Surgical Technologies currently Stryker) Bipolar Forceps 510O(k) K992931 510(k) K093108 (Stryker) Bissinger GmbH Claris Non-Stick Bipolar For… | 1999 |
| * | K093108 | Stryker Bipolar ForcepsSummary page 1…(subsequently Silverglide Surgical Technologies currently Stryker) Bipolar Forceps 510O(k) K992931 510(k) K093108 (Stryker) Bissinger GmbH Claris Non-Stick Bipolar Forceps 510(k) K05… | 2010 |
| * | K051429 | Claris Non-Stick Bipolar ForcepsSummary page 1…K992931 510(k) K093108 (Stryker) Bissinger GmbH Claris Non-Stick Bipolar Forceps 510(k) K051429 53 Predicate Devices… | 2005 |
| * | K014216 | Secca SystemSummary page 2…Guron Medical, Inc. (currently Mederi Therapeutics, Inc.) RF electrosurgical generator and accessories [510O(k) K01 4216] Description The HETTM Electrocautery System is comprised of the HETTM Bipolar Electrocautery Forceps and the HETTM Monitor. Th… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121085 | Het Bipolar Ligator System | 2012 | 2 |
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 19 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K121085 (Het Systems, LLC, 2012) has gone furthest, with 2 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. 2011, 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?
HET Bipolar Electrocautery Forceps is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The accessory monitor provides power for a timer, a temperature sensor and an LED light source mounted on the disposable forceps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110143: Het Bipolar Electrocautery Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110143
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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