Cleared Traditional

SCLERAL PLUGS, 19 AND 20 GAUGE

K022186 · Microvision, Inc. · Ophthalmic

Feb 2003

Decision

236d

Days

Class 2

Risk

About This 510(k) Submission

K022186 is an FDA 510(k) clearance for the SCLERAL PLUGS, 19 AND 20 GAUGE, a Plug, Scleral (Class II — Special Controls, product code LXP), submitted by Microvision, Inc. (Seabrook, US). The FDA issued a Cleared decision on February 26, 2003, 236 days after receiving the submission on July 5, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4155.

Submission Details

510(k) Number	K022186 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2002
Decision Date	February 26, 2003
Days to Decision	236 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	LXP — Plug, Scleral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4155
Definition	Intended To Provide Temporary Closure Of A Scleral Incision During An Ophthalmic Procedure.