510(k) · Cleared
ClearedAdaptable Monopolar Adaptable and/or Retractable Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 5, 2006 as substantially equivalent to K053282 (Pajunk GmbH, 2005) and 2 other predicates after a 77-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 5, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K935270 (1994). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
- 2 generations backK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
- 1 generation backK053282 Adaptable Monopolar Electrodes with Ceramic TipPajunk GmbH · 2005
- This deviceK062047 Adaptable Monopolar Adaptable and/or Retractable ElectrodesPAJUNK GmbH Medizintechnologie · 2006
- Descendant · cites it directly · 0 of its ownK190168 Aquas ProbesGenicon, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK073498 Laparoscopic and Electrosurgical Instruments and Accessories…Rudolf Medical GmbH + Co. KG · 2008
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 | K935270 | Modular Forcep and Scissor System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −2 | K033249 | Pajunk Modular Handle Instruments | Pajunk GmbH | 2004 | — |
| −1 | K053282 | Adaptable Monopolar Electrodes with Ceramic Tip | Pajunk GmbH | 2005 | — |
| 0 (this device) | K062047 | Adaptable Monopolar Adaptable and/or Retractable Electrodes | PAJUNK GmbH Medizintechnologie | 2006 | — |
| +1 | K190168 | Aquas Probes | Genicon, Inc. | 2019 | — |
| +1 | K073498 | Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy… | Rudolf Medical GmbH + Co. KG | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K053282 | Adaptable Monopolar Electrodes with Ceramic Tip Our reading of the summary gave K063282, FDA’s number for Contiplex Stim Continuous Nerve Block Set (B.Braun Medical, Inc.), decided Jun 20, 2007, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pajunk's monopolar Ceramic Tip electrodes”. | 2005 |
| * | K011997 | Modular Valve Handles for Adaptable Tubes, Model 1298-XX-XX, 1295-XX-XXSummary page 1…unks monopolar Ceramic Tip electrodes K063282 2. Pajunks Modular valve handles for adaptable tubes K011997 3. Pajunks monopolar electrodes marketed under K033249 PMN K062047… | 2001 |
| * | K033249 | Pajunk Modular Handle InstrumentsSummary page 1…s Modular valve handles for adaptable tubes K011997 3. Pajunks monopolar electrodes marketed under K033249 PMN K062047 006 === Page 2… | 2004 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K190168 (Genicon, Inc., 2019) 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?
Pajunks HF Electrodes are instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062047: Adaptable Monopolar Adaptable and/or Retractable Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062047
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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