Cleared Traditional

THE FUGO BLADE FOR GLAUCOMA

K041019 · Medisurg , Ltd. · Ophthalmic

Oct 2004

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K041019 is an FDA 510(k) clearance for the THE FUGO BLADE FOR GLAUCOMA, a Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered (Class II — Special Controls, product code NCR), submitted by Medisurg , Ltd. (Norristown, US). The FDA issued a Cleared decision on October 8, 2004, 171 days after receiving the submission on April 20, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number	K041019 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2004
Decision Date	October 08, 2004
Days to Decision	171 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	NCR — Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4100