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Prisma Disposable 19 and 20 Gauge Scleral Plugs

by Advanced Surgical Products, Inc.

510(k) K880952

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880952 Date13 May 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LXP
Device Class
Class II
Regulation
21 CFR Part 886.4155
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye.

The device is supplied sterile and is for single-use only. It is available in 19 and 20 gauge sizes and is indicated for use in ophthalmic surgical settings.

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