# K143175: AEx Generator; PlasmaBlade T

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy
- Decided: Dec 31, 2014 after 57 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: 7 generations back to K954171 (1996). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052859: Aquamantys Pump Generator System, Tissuelink Medical, Inc. (2005) Summary page 4.
- K082786: Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection Devices, Peak Surgical, Inc. (2008) Summary page 4.
- K111732: Aquamantys SBS 5.0 Sheated Biopolar Sealer, Salient Surgical Technologies, Inc. (2011) Summary page 4.
- K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar, Medtronic Advanced Energy, LLC (2013) Summary page 4.

## Most influential descendants
- K170610: PlasmaBlade T (2017), 0 descendants of its own

## Indications for use
The AEX Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF energy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological, Thoracic, and Open Abdominal Surgery procedures. The device is not intended for contraceptive tubal coagulation (Permanent Female Sterilization). The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saline for hemostatic sealing and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, Thoracic, and Open abdominal surgery procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K143175
Methodology: https://510kreport.com/methodology