510(k) · Cleared
ClearedBitech Bipolar Scissors
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 Oct 27, 2004 as substantially equivalent to K981361 (ETHICON, Inc., 1998) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Oct 27, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945975 (1994). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 1 generation backK972558 Bipolar ScissorsEnable Medical Corp. · 1997
- This deviceK042077 Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 2004
- Descendant · cites it directly · 1 of its ownK060232 Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK261179 AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH · 2026
- Descendant · cites it directly · 0 of its ownK082505 KLS Martin Electrosurgical InstrumentsKl Martin L.P. · 2009
- Descendant · cites it directly · 0 of its ownK073498 Laparoscopic and Electrosurgical Instruments and Accessories…Rudolf Medical GmbH + Co. KG · 2008
Most influential descendants
Showing 4 of 4 · See all- K060232Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 2006 · cites it directly1descendant
- K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH · 2026 · 2 generations on0descendants
- K082505KLS Martin Electrosurgical InstrumentsKl Martin L.P. · 2009 · cites it directly0descendants
- K073498Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf SystemRudolf Medical GmbH + Co. KG · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −1 | K972558 | Bipolar Scissors | Enable Medical Corp. | 1997 | — |
| 0 (this device) | K042077 | Bitech Bipolar Scissors | Guenter Bissinger Medizintechnik GmbH | 2004 | — |
| +1 | K060232 | Trokamed GMBH Electrosurgical Instruments & Accessories | Trokamed GmbH | 2006 | 10 |
| +2 | K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026 | — |
| +1 | K082505 | KLS Martin Electrosurgical Instruments | Kl Martin L.P. | 2009 | — |
| +1 | K073498 | Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy… | Rudolf Medical GmbH + Co. KG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K981361 | Powerstar Bipolar ScissorsSummary page 1…tantial Equivalence BiTech Bipolar Scissors are substantially equivalent to other legally marketed Bipolar Scissors from different manufacturers, e.g. Ethicon, Inc. (K981361); Enable, (K972558). 4. Description of the Device BiTech bipolar scissors enable cutting and dissection with simulataneous b… | 1998 |
| * | K972558 | Bipolar ScissorsSummary page 1…ech Bipolar Scissors are substantially equivalent to other legally marketed Bipolar Scissors from different manufacturers, e.g. Ethicon, Inc. (K981361); Enable, (K972558). 4. Description of the Device BiTech bipolar scissors enable cutting and dissection with simulataneous bipolar coagulation. The… | 1997 |
What descends from it? (4)
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 10 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K060232 (Trokamed GmbH, 2006) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K981361.
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?
BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
The BiTech Bipolar Scissors 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 as stated in the FDA summary.
https://510kreport.com/device/K042077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042077: Bitech Bipolar Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042077
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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