Cleared Traditional

PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS

K880952 · Advanced Surgical Products, Inc. · Ophthalmic

May 1988

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K880952 is an FDA 510(k) clearance for the PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS, a Plug, Scleral (Class II — Special Controls, product code LXP), submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on May 13, 1988, 67 days after receiving the submission on March 7, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4155.

Submission Details

510(k) Number	K880952 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 1988
Decision Date	May 13, 1988
Days to Decision	67 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.