NCRClass II

Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered

Ophthalmic · 21 CFR 886.4100

MDR events0All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances3All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Medisurg Research & Management Corp
TerminatedAug 2, 2006
Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000 Anterior Capsulotomy Unit. For Ophthalmic Use Only. The product is shipped
No documentation to support shelf life/sterility
Z-1224-06 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

Blue Line Sterilization Services
Novato, CA, US

510(k) clearances

3 clearances for this product code