# K041019: The Fugo Blade for Glaucoma

- Pathway: 510(k) (Traditional)
- Applicant: Medisurg, Ltd.
- Decided: Oct 8, 2004 after 171 days
- Product code: NCR (Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) The Fugo Blade for anterior capsulotomy: named in the summary without a submission number

## Most influential descendants
- K063468: The Fugo Blade for Dentistry (2007), 0 descendants of its own

## Indications for use
Sclerostomy for the treatment of primary open-angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed.

Source page: https://510kreport.com/device/K041019
Methodology: https://510kreport.com/methodology