# K170610: PlasmaBlade T

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy
- Decided: Apr 13, 2017 after 43 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: 8 generations back to K954171 (1996). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143175: AEx Generator; PlasmaBlade T, Medtronic Advanced Energy (2014) 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.
- K093695: Peak Plasmablade 3.OS Tissue Dissection Device, Peak Surgical, Inc. (2010) Summary page 4.

## Indications for use
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 PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K170610
Methodology: https://510kreport.com/methodology