510(k) · Cleared
ClearedMegadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 27, 2020 as substantially equivalent to K141587 (Megadyne Medical Products, Inc., 2015) after a 114-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- May 27, 2020
- Review
- 114 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961616 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK961616 Telescoping Penevac (Modification)I.C Medical, Inc. · 1996
- 1 generation backK141587 E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle…Megadyne Medical Products, Inc. · 2015
- This deviceK200253 Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne…Ethicon Endo-Surgery · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961616 | Telescoping Penevac (Modification) | I.C Medical, Inc. | 1996 | — |
| −1 | K141587 | E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa… | Megadyne Medical Products, Inc. | 2015 | — |
| 0 (this device) | K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne… | Ethicon Endo-Surgery | 2020 | — |
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? (1)
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 |
|---|---|---|---|
| * | K141587 | E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter…Summary page 4…21 CFR 878.4400 Product Code: GEI Device Class: Class II Panel: General and Plastic Surgery Predicate Device: K141587, ZIP PEN Smoke Evacuation Electrosurgical Pencils Reference Device: K081791, E-Z Clean Electrosurgical Electrodes Dev… | 2015 |
| † | K081791 | E-Z Clean Electrosurgical Electrode | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K141587.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
MEGADYNE™ Telescoping Soft Tissue Dissectors are monopolar devices designed for general electrosurgical applications including cutting and coagulation (coag). The devices conduct an electrosurgical current from an electrosurgical unit (ESU) and deliver it to the target tissue to achieve the desired surgical effect. The electrosurgical active electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the ESU to target…
Read the full statement (274 words)
MEGADYNE™ Telescoping Soft Tissue Dissectors are monopolar devices designed for general electrosurgical applications including cutting and coagulation (coag). The devices conduct an electrosurgical current from an electrosurgical unit (ESU) and deliver it to the target tissue to achieve the desired surgical effect. The electrosurgical active electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the ESU to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization. The electrosurgical active electrodes have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the MEGADYNE™ ESU’s Advanced Cutting Effect (ACE) mode or the MEGADYNE™ ESU’s Geometric Electron Modulation (GEM) mode.
MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissectors and MEGADYNE Telescoping Smoke Evacuation Pencils are monopolar devices designed for general electrosurgical applications including cutting and coagulation (coag) and for removing smoke generated by electrosurgery when used in conjunction with a smoke evacuation system. The devices conduct an electrosurgical current from an electrosurgical unit (ESU) and deliver it to the target tissue to achieve the desired surgical effect. The [Megadyne PTFE coated] electrosurgical active electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the ESU to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
The [MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissector] electrosurgical active electrodes have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the MEGADYNE™ ESU’s Advanced Cutting Effect (ACE) mode or the MEGADYNE™ ESU’s Geometric Electron Modulation (GEM) mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200253: Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200253
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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