# K974232: Essential Shaver System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Jan 12, 1998 after 61 days
- Product code: EQJ (Bur, Ear, Nose And Throat)
- Device class: 1
- Regulation: 21 CFR 874.4140
- 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 K953096 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953096: Essential Shaver System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- (no number) Xomed XPS System used with the STRAIGHTSHOT, PERFORMA and SKEETER handpieces: named in the summary without a submission number
- (no number) ESSential Shaver System: named in the summary without a submission number

## Indications for use
The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could 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, 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 at the cerebellopontine angle.

Source page: https://510kreport.com/device/K974232
Methodology: https://510kreport.com/methodology