# K150297: PlasmaBlade UPPP and Suction Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy
- Decided: May 21, 2015 after 104 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: 14 generations back to K936109 (1994). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083415: Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device, Peak Surgical, Inc. (2009) Summary page 5.
- K014290: Entec Plasma Wands, Arthrocare Corp. (2002) Summary page 5.
- K103775: Peak Suction Coagulator, Peak Surgical, Inc. (2011) Summary page 5.

## Indications for use
The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including, uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal, Tubal, Palatine). The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.

Source page: https://510kreport.com/device/K150297
Methodology: https://510kreport.com/methodology