Cleared Traditional

K050933 - FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
(FDA 510(k) Clearance)

K050933 · Medisurg , Ltd. · Ophthalmic
Dec 2005
Decision
239d
Days
Class 2
Risk

K050933 is an FDA 510(k) clearance for the FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300, 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 December 9, 2005, 239 days after receiving the submission on April 14, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number K050933 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2005
Decision Date December 09, 2005
Days to Decision 239 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