510(k) · Cleared
ClearedEndoscopic Monopolar Instruments and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bema-GmbH & Co. KG · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 20, 2011 as substantially equivalent to K010192 (Antyllos Medizintechnik GmbH, 2001) and 3 other predicates after a 445-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Dec 20, 2011
- Review
- 445 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K935270 (1994). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
- 1 generation backK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
- This deviceK102921 Endoscopic Monopolar Instruments and AccessoriesBema-GmbH & Co. KG · 2011
- Descendant · cites it directly · 1 of its ownK171825 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic…Hunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK163615 Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK211019 Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK182013 EasyInstrumentsAgency For Medical Innovations GmbH · 2019
Most influential descendants
Showing 4 of 4 · See all- K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018 · cites it directly1descendant
- K163615Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc. · 2017 · cites it directly1descendant
- K211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesDannik, LLC · 2021 · 2 generations on0descendants
- K182013EasyInstrumentsAgency For Medical Innovations GmbH · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935270 | Modular Forcep and Scissor System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −1 | K033249 | Pajunk Modular Handle Instruments | Pajunk GmbH | 2004 | — |
| 0 (this device) | K102921 | Endoscopic Monopolar Instruments and Accessories | Bema-GmbH & Co. KG | 2011 | — |
| +1 | K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical… | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2018 | — |
| +1 | K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments | Carefusion 2200, Inc. | 2017 | — |
| +2 | K211019 | Disposable Monopolar Laparoscopic Tips and Reusable Handles | Dannik, LLC | 2021 | — |
| +2 | K182013 | EasyInstruments | Agency For Medical Innovations GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K010192 | Endoscopic Tube Shaft Instruments for Monoplar CoagulationSummary page 1…Classification Electrosurgical Cutting at Name: Coagulation Device at Accessories Predica te o K010192 - Endoscopic Tube Shaft Instruments for Device: Monopolar Coagulation o K(033249 - Pajunk… | 2001 |
| * | K033249 | Pajunk Modular Handle InstrumentsSummary page 2…cleared for marketing by K033249, Pajunk Modular ____________________Handle Instruments. Sterility… | 2004 |
| * | K970541 | Aesculap Modular Monopolar ElectrodesSummary page 1…Tube Shaft Instruments for Device: Monopolar Coagulation o K(033249 - Pajunk Modular Handle Instruments o K970541 -. Aesculap Modular Monopolar Electrodes o K003717 - Tekno Medical Instruments for Laparoscopy Device… | 1997 |
| * | K003717 | Instruments for Laparoscopy 5 MM, 10 MM with Coloured Handle, Detachable Endodcopic…Summary page 1…o K(033249 - Pajunk Modular Handle Instruments o K970541 -. Aesculap Modular Monopolar Electrodes o K003717 - Tekno Medical Instruments for Laparoscopy Device Endoscopic Monopolar Instruments and Accessories Description:… | 2001 |
| † | K930666 | Reusable Laparoscopic Instruments W/ Electrocautery | 1994 |
What descends from it? (4)
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 17 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K171825 (Hunan Handlike Minimally Invasive Surgery Co., Ltd., 2018) has gone furthest, with 1 descendant 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. 2011, 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?
Endoscapic Monopolar Instruments and Accessories are used in Laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monapatar high-frequency electrical current.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102921: Endoscopic Monopolar Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102921
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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