# K020594: Diego Powered Dissector and Drill System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Mar 8, 2002 after 14 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
61 later devices descend from it; 5 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Turbo 7000 System: named in the summary without a submission number

## Most influential descendants
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own
- K102003: Xpress Balloon Device (2010), 36 descendants of its own

## Indications for use
The Diego Powered Dissector and Drill System’s intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures. Sinus applications would embody: ethmoidectomy/sphenoethmoidectomy polypectomy septoplasty and procedures such as antrostomy endoscopic DCR frontal sinus drill-out frontal sinus trephination and irrigation septal spurs removal trans-spehnoidal procedures Nasopharyngeal/laryngeal procedures would comprise: adenoidectomy laryngeal lesion de-bulking laryngeal polypectomy tracheal procedures tonsillectomy Head & Neck procedures would encompass: soft tissue shaving rhinoplasty (narrowing 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 Otology procedures would include: mastoidectomy mastoidotomy.

Source page: https://510kreport.com/device/K020594
Methodology: https://510kreport.com/methodology