510(k) · Cleared
ClearedAesculap Modular Monopolar Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 28, 1997 after a 44-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Mar 28, 1997
- Review
- 44 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK970541 Aesculap Modular Monopolar ElectrodesAesculap, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK102921 Endoscopic Monopolar Instruments and AccessoriesBema-GmbH & Co. KG · 2011
- Descendant · cites it directly · 3 of its ownK053282 Adaptable Monopolar Electrodes with Ceramic TipPajunk GmbH · 2005
- Descendant · 2 generations on · 2 of its ownK062047 Adaptable Monopolar Adaptable and/or Retractable ElectrodesPAJUNK GmbH Medizintechnologie · 2006
- Descendant · 2 generations on · 1 of its ownK171825 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic…Hunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK163615 Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K102921Endoscopic Monopolar Instruments and AccessoriesBema-GmbH & Co. KG · 2011 · cites it directly4descendants
- K053282Adaptable Monopolar Electrodes with Ceramic TipPajunk GmbH · 2005 · cites it directly3descendants
- K062047Adaptable Monopolar Adaptable and/or Retractable ElectrodesPAJUNK GmbH Medizintechnologie · 2006 · 2 generations on2descendants
- K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018 · 2 generations on1descendant
- K163615Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970541 | Aesculap Modular Monopolar Electrodes | Aesculap, Inc. | 1997 | — |
| +1 | K102921 | Endoscopic Monopolar Instruments and Accessories | Bema-GmbH & Co. KG | 2011 | — |
| +1 | K053282 | Adaptable Monopolar Electrodes with Ceramic Tip | Pajunk GmbH | 2005 | — |
| +2 | K062047 | Adaptable Monopolar Adaptable and/or Retractable Electrodes | PAJUNK GmbH Medizintechnologie | 2006 | — |
| +2 | K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical… | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2018 | — |
| +2 | K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments | Carefusion 2200, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 113 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, K102921 (Bema-GmbH & Co. KG, 2011) has gone furthest, with 4 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 Modular Monopolar Electrodes presented in this submission are intended for use in endoscopic surgery (laparoscopy, thoracoscopy) for coagulation and dissection of selected tissue.
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/K970541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970541: Aesculap Modular Monopolar Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970541
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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