Cleared Traditional

THE FUGO BLADE

K001498 · Medisurg , Ltd. · Ophthalmic

Aug 2000

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K001498 is an FDA 510(k) clearance for the THE FUGO BLADE, 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 August 10, 2000, 87 days after receiving the submission on May 15, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number	K001498 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2000
Decision Date	August 10, 2000
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement

Device Classification

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