510(k) · Cleared
ClearedNon Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX, Monopolar Forceps Model 09/XXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Egon Faulhaber Surgical Instruments Pinzetten · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 21, 2010 after a 63-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jun 21, 2010
- Review
- 63 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK101080 Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model…Egon Faulhaber Surgical Instruments Pinzetten · 2010
- Descendant · cites it directly · 2 of its ownK182773 Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick…Faulhaber Pinzetten Ohg · 2019
- Descendant · 2 generations on · 1 of its ownK191847 Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt…Adeor Medical AG · 2020
- Descendant · 2 generations on · 0 of its ownK233351 Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip…Hg Innovations, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK131012 Sutter Bipolar Forceps - SuperglissSutter Medizintechnik GmbH · 2013
Most influential descendants
Showing 5 of 5 · See all- K182773Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating…Faulhaber Pinzetten Ohg · 2019 · cites it directly2descendants
- K191847Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick…Adeor Medical AG · 2020 · 2 generations on1descendant
- K233351Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable…Hg Innovations, Ltd. · 2023 · 2 generations on0descendants
- K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015 · cites it directly0descendants
- K131012Sutter Bipolar Forceps - SuperglissSutter Medizintechnik GmbH · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101080 | Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX… | Egon Faulhaber Surgical Instruments Pinzetten | 2010 | — |
| +1 | K182773 | Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar… | Faulhaber Pinzetten Ohg | 2019 | — |
| +2 | K191847 | Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use… | Adeor Medical AG | 2020 | — |
| +2 | K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable… | Hg Innovations, Ltd. | 2023 | — |
| +1 | K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | 2015 | — |
| +1 | K131012 | Sutter Bipolar Forceps - Supergliss | Sutter Medizintechnik GmbH | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | — | Bipolar and Monopolar Forceps from Guenter Bissinger Medizintechnik GmbH Named without a submission number | |
| * | — | Bipolar and Monopolar Forceps from Sutifer Medizintechnik GmbH Named without a submission number | |
| * | — | Bipolar and Monopolar Forceps from Kirwan Surgical Products (formerly New England… Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K182773 (Faulhaber Pinzetten Ohg, 2019) 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. 2010, 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?
The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar and monopolar coagulation for general surgery where coagulation of soft tissue is needed. The Bipolar Forceps are used with the bipolar, and the Monopolar Forceps are used with the monopolar output for standard electrosurgical generators. The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps have…
Read the full statement (120 words)
The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar and monopolar coagulation for general surgery where coagulation of soft tissue is needed. The Bipolar Forceps are used with the bipolar, and the Monopolar Forceps are used with the monopolar output for standard electrosurgical generators.
The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar 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.
The types of surgery intended are:
General surgery, Laryngeal coagulation, Orthopedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynecological coagulation (except for use in female sterilization), Urological coagulation, Ear-, Nose- and Throat coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101080: Non Stick Bipolar Forceps Model 07/XXX, Bipolar Forceps Model 08/XXX, Monopolar Forceps Model 09/XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101080
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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