Cleared Traditional

SCLERAL PLUGS, 19 AND 20 GAUGE

K990872 · Ophthalmic Consultants, Inc. · Ophthalmic

Jul 1999

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K990872 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 Ophthalmic Consultants, Inc. (Tooele, US). The FDA issued a Cleared decision on July 13, 1999, 119 days after receiving the submission on March 16, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4155.

Submission Details

510(k) Number	K990872 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 1999
Decision Date	July 13, 1999
Days to Decision	119 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.