510(k) · Cleared
ClearedBipolar Micro-Coagulation Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gunter Bissinger Medizintechnik GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 5, 2018 as substantially equivalent to K150959 (Sutter Medizintechnik GmbH, 2015) after a 241-day review. Its family tree reaches back 3 generations to 1979. 2 later devices descend from it.
- Decided
- Apr 5, 2018
- Review
- 241 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K792365 (1979). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK792365 Bipolar ForcepsConcept, Inc. · 1979
- 2 generations backK993655 Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · Recalled
- 1 generation backK150959 Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015
- This deviceK172368 Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018
- Descendant · cites it directly · 0 of its ownK253405 Prana SystemPrana Surgical · 2026
- Descendant · cites it directly · 0 of its ownK231615 Disposable Endoscopic BipolarJiangsu Hope Biomedical Science & Technology Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792365 | Bipolar Forceps | Concept, Inc. | 1979 | — |
| −2 | K993655 | Micro-France Electrosurgical Instruments, Various | Xomed, Inc. | 1999 | 2 |
| −1 | K150959 | Sutter Bipolar Forceps-Calvian | Sutter Medizintechnik GmbH | 2015 | — |
| 0 (this device) | K172368 | Bipolar Micro-Coagulation Forceps | Gunter Bissinger Medizintechnik GmbH | 2018 | — |
| +1 | K253405 | Prana System | Prana Surgical | 2026 | — |
| +1 | K231615 | Disposable Endoscopic Bipolar | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K150959 | Sutter Bipolar Forceps-CalvianSummary page 5…Predicate Device 510(k) Number 510(k) Holder Sutter Bipolar Forceps – Calvian K150959 Sutter Medizintechnik GmbH 5. Device Description Bipolar Micro-Coagulation Forceps are electrosurgica… | 2015 |
What descends from it? (2)
2 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 39 years and passes through 4 companies; a new generation was cleared every 15.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K253405 (Prana Surgical, 2026) has gone furthest, with 0 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. 2018, 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?
Bipolar Micro-Coagulation Forceps are intended to remove tissue and control bleeding.
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/K172368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172368: Bipolar Micro-Coagulation Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172368
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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