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Scleral Plugs, 19 and 20 Gauge

by Ophthalmic Consultants, Inc.

510(k) K990872

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 NumberK990872 Date13 Jul 1999ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

Scleral plugs are ophthalmic surgical instruments used to maintain patency of a previously made incision in the sclera of the eye during ophthalmic surgical procedures. They are available in 19 and 20 gauge sizes, with the 19 gauge plugs being gold-plated stainless steel and the 20 gauge plugs being silver-plated. These plugs are provided as part of single- and multiple-use surgical component kits/packs or as kit replacements.

The scleral plugs are operated by certified clinicians in clinical settings and are intended for maintaining incision patency during ophthalmic procedures. They are supplied in packages containing 4 plugs per size, with 3 sizes available in some sets. The device has FDA 510(k) clearance with product code LXP and is classified as a Class II device under regulation number 886.4155.

Other devices from Ophthalmic Consultants, Inc.

Questions

AI-generated answers, 21 Sep 2026

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

  • What are scleral plugs used for in ophthalmic surgery?

    Scleral plugs are ophthalmic surgical instruments designed to maintain patency of previously made incisions in the sclera of the eye during various ophthalmic surgical procedures. They help ensure proper access and visibility during surgery.

  • What sizes and materials are available for these scleral plugs?

    The scleral plugs are available in 19 and 20 gauge sizes. The 19 gauge plugs are made of gold-plated stainless steel, while the 20 gauge plugs are silver-plated. This provides clinicians with options based on their specific surgical needs.

  • How are the scleral plugs supplied and are they single-use or reusable?

    Scleral plugs are supplied as part of single- and multiple-use surgical component kits/packs or as kit replacements. They are provided in packages containing 4 plugs per size, with some sets offering 3 different sizes to accommodate various surgical requirements.

  • What is the regulatory status of these scleral plugs?

    The scleral plugs have FDA 510(k) clearance with product code LXP and are classified as a Class II device under regulation number 886.4155. This indicates they meet specific safety and effectiveness requirements for ophthalmic surgical use.