# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery
- Decided: May 27, 2020 after 114 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961616 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141587: E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter, Charcoal Filter, Adapter, Megadyne Medical Products, Inc. (2015) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K200253
Methodology: https://510kreport.com/methodology