# K030343: Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: May 2, 2003 after 88 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020594 (2002). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020594: Diego Powered Dissector and Drill System, Gyrus Ent LLC (2002) Summary page 1.

## Most influential descendants
- K123429: Olympus Energy Power System (Eps) (2013), 1 descendant of its own
- K212650: Celeris, Disposable Sinus Debrider (2022), 0 descendants of its own
- K080052: Stryker Essx with Navigation Mount (2008), 0 descendants of its own

## Indications for use
The intended use of the Diego Powered Dissector and Drill System is the cutting and removal of bone and tissue in general ENT, Head & Neck, and atoneurologic procedures. Sinus applications would embody: ethrnoidectomy/sphenoethmoidectomy polypectomy septoplasty and procedures such as antrostomy endoscopic DCR frontal sinus drill-out frontal sinus trephination and irrigation septal spurs removal trans-spehn oidal procedures NasopharyngeaIAaryngeal procedures would comprise: adenoidedomy laryngeal lesion de-bulking laryngeal polypectomy tracheal procedures tonsillectomy Otology procedures would include: mastoidectomy mastoidotomy. Head & Neck procedures would encompass: soft tissue shaving rhinoplasty (narrowlng of the bony vault and revision of the bony pyramid) removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face acoustic neuroma removal

Source page: https://510kreport.com/device/K030343
Methodology: https://510kreport.com/methodology