510(k) · Cleared
ClearedClaris Non-Stick Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guenter Bissinger Medizintechnik GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 29, 2005 as substantially equivalent to K992931 (Silverglide Surgical Technologies, 1999) after a 58-day review. Its family tree reaches back 3 generations to 1992. 21 later devices descend from it.
- Decided
- Jul 29, 2005
- Review
- 58 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923332 (1992). 5 ancestors in all. 21 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 2 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 1 generation backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- This deviceK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- Descendant · cites it directly · 14 of its ownK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- Descendant · 2 generations on · 13 of its ownK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 10 of its ownK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- Descendant · 4 generations on · 3 of its ownK152219 PK AIMGyrus Acmi, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K070997Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables…Pro-Med Instruments GmbH · 2007 · cites it directly14descendants
- K083162Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · 2 generations on13descendants
- K093108Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010 · 3 generations on10descendants
- K152219PK AIMGyrus Acmi, Inc. · 2015 · 4 generations on3descendants
- K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −2 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −1 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| 0 (this device) | 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 | — |
| +2 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| +3 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| +4 | K152219 | PK AIM | Gyrus Acmi, Inc. | 2015 | — |
| +1 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K992931 | Non-Stick Bipolar ForcepsSummary page 2…are substantially equivalent to other legally marketed Bipo- lar Forceps from different manufacturers, e.g. Link Technology, Inc. / Silverglide Surgical Tech- nologies, K992931. 4. Description of the Device During the coagulation of tissue the coagulated tissue might stick to the tip of the forceps. This… | 1999 |
What descends from it? (21)
See all 218 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables… | 2007 | 14 |
| K110143 | Het Bipolar Electrocautery Forceps | 2011 | 3 |
| K213042 | Supra Non-Stick Bipolar Forceps | 2022 | 0 |
| K131012 | Sutter Bipolar Forceps - Supergliss | 2013 | 0 |
| K082505 | KLS Martin Electrosurgical Instruments | 2009 | 0 |
| K073498 | Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf System | 2008 | 0 |
| K061635 | MSD Bipolar Forceps | 2006 | 0 |
| K052702 | Misonix Inc. FS-1000-RF Bipolar Forceps Accessory | 2005 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K070997 (Pro-Med Instruments GmbH, 2007) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K992931.
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?
The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.
The Bissinger CLARIS NON-STICK bipolar forceps has 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/K051429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051429: Claris Non-Stick 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/K051429
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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