Cleared Traditional

DISPOSABLE SCLERAL PLUGS

K925671 · O.R. Specialties, Inc. · Ophthalmic

Aug 1993

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K925671 is an FDA 510(k) clearance for the DISPOSABLE SCLERAL PLUGS, a Plug, Scleral (Class II — Special Controls, product code LXP), submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on August 2, 1993, 265 days after receiving the submission on November 10, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4155.

Submission Details

510(k) Number	K925671 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 1992
Decision Date	August 02, 1993
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement

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.