Disposable Scleral Globe Plug LXP

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

Full name

Disposable Scleral Globe Plug

510(k) Number

K840693 ↗

FDA Product Code

LXP

Device Class

Class II

Regulation

21 CFR Part 886.4155

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Heslin Dispos. Tubing Set

  Class II

  FDA 510(k) K843041 Active Cleared 21 Nov 1984

• Phacoemulsification Kits

  Class II

  FDA 510(k) K840695 Active Cleared 22 May 1984

• Acuvac(Tm) Suction Reservoir 400cc and

  Class I

  FDA 510(k) K801350 Active Cleared 14 Jul 1980

• Irrigation, Aspiration Tubing Sets

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  FDA 510(k) K841072 Active Cleared 29 Mar 1984

• Ispvac Tm

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  FDA 510(k) K802973 Active Cleared 19 Dec 1980

• Disposable Tubing Sets

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  FDA 510(k) K820680 Active Cleared 9 Apr 1982

See all devices from Innovative Surgical Products, Inc. →

• What is the Disposable Scleral Globe Plug LXP used for?

  The Disposable Scleral Globe Plug LXP is designed for temporary closure of a scleral incision during ophthalmic surgical procedures. Its purpose is to maintain intraocular pressure stability and prevent fluid leakage, allowing surgeons to perform precise interventions with confidence. This is particularly important in controlled surgical environments where maintaining ocular integrity is critical.

• Is the Disposable Scleral Globe Plug LXP single-use or reusable?

  The Disposable Scleral Globe Plug LXP is explicitly intended for single-use only. It is supplied sterile and meant for intraoperative application during a single surgical procedure. Reuse is not recommended or supported, as it could compromise sterility and device integrity, potentially leading to complications during surgery.

• How should the Disposable Scleral Globe Plug LXP be stored?

  Storage must adhere to standard surgical instrument guidelines to preserve sterility and functionality. The device should be kept in its original, sealed packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or contamination. Always follow manufacturer instructions for unpacking and handling to ensure the device remains sterile and effective for its intended use.

• What regulatory approval does the Disposable Scleral Globe Plug LXP hold?

  The Disposable Scleral Globe Plug LXP holds FDA 510(k) clearance under the reference number K840693. It is classified as substantially equivalent to its predicate device and falls under the regulatory scope of 21 CFR 886.4155. This clearance confirms that the device meets FDA requirements for safety and effectiveness as an ophthalmic surgical tool.

• Can this device be used in any ophthalmic surgery, or are there specific procedures it is intended for?

  While the Disposable Scleral Globe Plug LXP is classified as a Class 2 ophthalmic device and intended for temporary closure of scleral incisions, its specific use depends on the surgeon’s discretion and the requirements of the procedure. It is particularly suited for surgeries where maintaining intraocular pressure and preventing fluid leakage are critical, such as certain types of cataract surgeries or corneal transplants. Always consult the device’s instructions for use and surgical guidelines for proper application.