# K034004: Diego RF Powered Dissector and Drill System Console

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Mar 3, 2004 after 70 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
Longest line of descent: 9 generations back to K936109 (1994). 71 ancestors in all.
50 later devices descend from it; 6 cite it directly.
0 of 122 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.
- K994365: Dyonics Electroblade, Smith & Nephew, Inc. (2000) Summary page 1.
- K012314: Dyonics Electroblade Resector, Smith & Nephew, Inc. (2002) Summary page 1.
- K031675: Smith & Nephew Dyonics Electroblade Resector, Smith & Nephew, Inc. (2003) Summary page 1.
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes), Gyrus Ent LLC (2002) Summary page 1.
- K030108: Arthrocare Ent Coblator Surgery System, Arthrocare Corp. (2003) Summary page 1.
- K001986: Surgitron Iec II, Ellman Intl., Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K112506: Xpress Multi-Sinus Dilation Tool (2011), 21 descendants of its own

## Indications for use
The Diego RF 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 & 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/K034004
Methodology: https://510kreport.com/methodology