510(k) · Cleared
Recalled · Class II · 2014Trokamed GMBH Electrosurgical Instruments & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trokamed GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 12, 2006 as substantially equivalent to K973341 (Richard Wolf Medical Instruments Corp., 1997) and 5 other predicates after a 163-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled 10 times.
- Decided
- Jul 12, 2006
- Review
- 163 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 10
- Predicates
- 6
Its longest line of descent runs back 3 generations to K945975 (1994). 15 ancestors in all, the oldest K913281 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 2 generations backK972558 Bipolar ScissorsEnable Medical Corp. · 1997
- 1 generation backK042077 Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 2004
- This deviceK060232 Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 2006
- Descendant · cites it directly · 0 of its ownK261179 AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH · 2026
Most influential descendants
Showing 1 of 1 · See all- K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −2 | K972558 | Bipolar Scissors | Enable Medical Corp. | 1997 | — |
| −1 | K042077 | Bitech Bipolar Scissors | Guenter Bissinger Medizintechnik GmbH | 2004 | — |
| 0 (this device) | K060232 | Trokamed GMBH Electrosurgical Instruments & Accessories | Trokamed GmbH | 2006 | — |
| +1 | K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K973341 | Hook Electrode, Needle Electrode, Coagulation Button ElectrodeSummary page 2…and reused. 4. SUBSTANTIAL EQUIVALENCE Manufacturer 510(k) Number Device name A Richard Wolf K973341 Unipolar electrodes B Valleylab K964602 Valleylab… | 1997 |
| * | K964602 | Davis Bayonet ElectrodesSummary page 2…ber Device name A Richard Wolf K973341 Unipolar electrodes B Valleylab K964602 Valleylab coated electrodes C Megadyne K040699 Le… | 1997 |
| * | K040699 | Laparoscopic Electrode, Reusable Indicator Shaft (Leris)Summary page 2…Unipolar electrodes B Valleylab K964602 Valleylab coated electrodes C Megadyne K040699 Leris D Bissinger K042077 BiTech Bipolar Scissors… | 2004 |
| * | K042077 | Bitech Bipolar ScissorsSummary page 2…Valleylab coated electrodes C Megadyne K040699 Leris D Bissinger K042077 BiTech Bipolar Scissors E Karl Storz K960757 Karl S… | 2004 |
| * | K960757 | Karl Storz Ureter ResectoscopeSummary page 2…Leris D Bissinger K042077 BiTech Bipolar Scissors E Karl Storz K960757 Karl Storz Ureter Resectoscope F COMEG Endoscopy K971881… | 1996 |
| * | K971881 | Comeg Resectoscope and Laser-Resectoscope Working…Summary page 2…BiTech Bipolar Scissors E Karl Storz K960757 Karl Storz Ureter Resectoscope F COMEG Endoscopy K971881 Comeg Resectoscope and... 5. BIOCOMPATIBILITY The biocompatibility has been approved based on ISO 109… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261179 | AlphaTriPart - Monopolar MIC Instruments | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 30, 2014 | Class II | Z-2729-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2722-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2721-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2728-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2725-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2727-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2726-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2723-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2730-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
| May 30, 2014 | Class II | Z-2724-2014 | Labeling design | Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar… |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K261179 (Gimmi GmbH, 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.
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 Trokamed GmbH Resectoscope & Accessories are indicated for the resection of prostate tissue.
The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used.
The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.
The instruments are reusable; they are intended to be cleaned, sterilized and reused.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K060232: Trokamed GMBH Electrosurgical Instruments & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K060232
Report an extraction error
Are you the manufacturer?
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