# K181257: PlasmaBlade X 3.0S, PlasmaBlade X 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy
- Decided: Aug 2, 2018 after 83 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: 5 generations back to K933157 (1994). 21 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073057: Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040, Peak Surgical, Inc. (2008) Summary page 4.
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices, Peak Surgical, Inc. (2008) Summary page 4.
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device, Peak Surgical, Inc. (2010) Summary page 4.

## Most influential descendants
- K193579: PlasmaBlade X 3.0S LIGHT (2020), 2 descendants of its own
- K242266: PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (2024), 1 descendant of its own
- K250483: PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (2025), 0 descendants of its own

## Indications for use
The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.

Source page: https://510kreport.com/device/K181257
Methodology: https://510kreport.com/methodology