# K083013: PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered Dissector Handpiece, Model 7033-9001

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 9, 2008 after 61 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: 10 generations back to K936109 (1994). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034004: Diego RF Powered Dissector and Drill System Console, Gyrus Ent LLC (2004) Summary page 2.
- K012488: Modification to:Endius Bipolar Sheath, Endius, Inc. (2001) Summary page 2.
- K973499: XPS Straightshot Microbrider System or Trebay Shaver System, Xomed, Inc. (1998) Summary page 2.

## Indications for use
The Diego PK System is intended for cutting, coagulation and removal of bone and tissue in general ENT, Head & Neck, Otoneurologic and various spinal surgical procedures.

Source page: https://510kreport.com/device/K083013
Methodology: https://510kreport.com/methodology