Cleared Traditional

SCLERAL PLUG

K831193 · Medical Instrument Development Laboratories, Inc. · Ophthalmic

Jun 1983

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K831193 is an FDA 510(k) clearance for the SCLERAL PLUG, a Plug, Scleral (Class II — Special Controls, product code LXP), submitted by Medical Instrument Development Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983, 79 days after receiving the submission on April 12, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4155.

Submission Details

510(k) Number	K831193 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 1983
Decision Date	June 30, 1983
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—

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.