# K081814: Reprocessed Ent Shavers

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Dec 17, 2008 after 174 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. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“7013-8100”).
- (no number) Gyrus Diego shavers: named in the summary without a submission number
- (no number) Medtronic Xomed XPS shavers: named in the summary without a submission number

## Indications for use
The reprocessed ENT shavers are intended to be used with a reusable hand piece and are designed for use in various ENT, head and neck surgeries and otoneurologic procedures. Sinus Applications: * Polypectomy * Ethmoidectomy/Sphenoethmoidectomy * Septoplasty * Antrostomy * Endoscopic DCR * Frontal Sinus Trephination and Irrigation * Frontal Sinus Drill Out * Septal Spur Removal * Trans-Sphenoidal Procedures Head and Neck Procedures * Rhinoplasty Lipodebridement in the Maxillary and Mandibular Region * Soft Tissue Shaving * Acoustic Neuroma Removal Nasopharyngeal and Laryngeal Procedures * Tonsillectomy * Tracheal Procedures * Adenoidectomy * Laryngeal Lesion De-Bulking * Laryngeal Polypectomy Otology Procedures * Mastoidotomy * Mastoidectomy

Source page: https://510kreport.com/device/K081814
Methodology: https://510kreport.com/methodology