# K001498: The Fugo Blade

- Pathway: 510(k) (Traditional)
- Applicant: Medisurg, Ltd.
- Decided: Aug 10, 2000 after 87 days
- Product code: NCR (Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
59 later devices descend from it; 5 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own

## Recalls of this device
- Apr 28, 2006 · Not classified · Z-1224-06: No documentation to support shelf life/sterility

Source page: https://510kreport.com/device/K001498
Methodology: https://510kreport.com/methodology