# K063468: The Fugo Blade for Dentistry

- Pathway: 510(k) (Traditional)
- Applicant: Medisurg, Ltd.
- Decided: Apr 18, 2007 after 153 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- 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 K000768 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000768: Wallach Quantum 500 Electrosurgical Generator, Wallach Surgical Devices, Inc. (2000) Summary page 1.
- K001498: The Fugo Blade, Medisurg, Ltd. (2000) Summary page 1.
- K041019: The Fugo Blade for Glaucoma, Medisurg, Ltd. (2004) Summary page 1.
- K050933: Fugo Blade for Peripheral Iridotomy, Model M300, Medisurg, Ltd. (2005) Summary page 1.

## Indications for use
Excisional and incisional biopsy Exposure of tnerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Leukoplakia Operculectomy Gingivoplasty (contouring of gingival tissue) Gingivectomy (excision of unsupported gingival tissue) Gingival incision and excision Hemostatis Implant recovery Incision and drainage of abscess Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion removal Tumor removal

Source page: https://510kreport.com/device/K063468
Methodology: https://510kreport.com/methodology