Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4155](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4155) → LXP — Plug, Scleral # LXP · Plug, Scleral _Ophthalmic · 21 CFR 886.4155 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP ## Overview - **Product Code:** LXP - **Device Name:** Plug, Scleral - **Regulation:** [21 CFR 886.4155](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4155) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) ## Identification 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 These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery. ## Classification Rationale Class II (special controls). The special controls for the scleral plug are as follows: ## Special Controls *Classification.* Class II (special controls). The special controls for the scleral plug are as follows:(1) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; and (iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device. (2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are: (i) The device must be demonstrated to be sterile during the labeled shelf life; (ii) The device must be demonstrated to be biocompatible; (iii) Characterization of the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and (vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device. ## Recent Cleared Devices (10 of 10) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K022186](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K022186.md) | SCLERAL PLUGS, 19 AND 20 GAUGE | Microvision, Inc. | Feb 26, 2003 | SESE | | [K990872](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K990872.md) | SCLERAL PLUGS, 19 AND 20 GAUGE | Ophthalmic Consultants, Inc. | Jul 13, 1999 | SESE | | [K945114](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K945114.md) | VISITEC SCLERAL PLUG | Visitec Co. | Feb 23, 1995 | SESE | | [K925671](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K925671.md) | DISPOSABLE SCLERAL PLUGS | O.R. Specialties, Inc. | Aug 2, 1993 | SESE | | [K880953](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K880953.md) | ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG | Advanced Surgical Products, Inc. | May 13, 1988 | SESE | | [K880952](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K880952.md) | PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS | Advanced Surgical Products, Inc. | May 13, 1988 | SESE | | [K871604](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K871604.md) | MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS | Advanced Surgical Products, Inc. | Jun 12, 1987 | SESE | | [K854507](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K854507.md) | STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS | Storz Instrument Co. | Feb 7, 1986 | SESE | | [K840693](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K840693.md) | DISPOSABLE SCLERAL GLOBE PLUG | Innovative Surgical Products, Inc. | May 22, 1984 | SESE | | [K831193](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP/K831193.md) | SCLERAL PLUG | Medical Instrument Development Laboratories, Inc. | Jun 30, 1983 | SESE | ## Top Applicants - Advanced Surgical Products, Inc. — 3 clearances - Innovative Surgical Products, Inc. — 1 clearance - Medical Instrument Development Laboratories, Inc. — 1 clearance - Microvision, Inc. — 1 clearance - O.R. Specialties, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LXP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com