# K992994: Turbo 7000 Shaver and Drill Console; Turbo 7000 Handpieces; Essential Shaver/Burrs;

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Nov 23, 1999 after 77 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Xomed XPS™ System used with the STRAIGHTSHOT™, PERFORMA™ and SKEETER™ handpieces: named in the summary without a submission number
- (no number) Modified ESSential Shaver: named in the summary without a submission number

## Indications for use
The Turbo 7000™ System’s intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures would include: mastoidectomy and mastoidotomy. Sinus applications would embody: septoplasty and procedures such as the removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR and trans-spehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise: adenoidectomy, tracheal, laryngeal polyectomy, laryngeal lesion debulking and tonsillectomy. Head and neck procedures would encompass: soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal. Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures.

Source page: https://510kreport.com/device/K992994
Methodology: https://510kreport.com/methodology