Plug, Scleral
The Scleral Plug (product code LXP) is an ophthalmic device intended to provide temporary closure of a scleral incision during an eye surgical procedure, maintaining intraocular pressure and preventing fluid egress while the surgeon works. Regulated under 21 CFR 886.4155 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the Ophthalmic medical specialty. It is not flagged as an implant or life-sustaining device, and is not eligible for third-party review.
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Basic Information
- Product Code
- LXP
- Device Class
- FDA class 2
- Regulation Number
- 886.4155
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022186 | SCLERAL PLUGS, 19 AND 20 GAUGE | Feb 26, 2003 | Substantially Equivalent | Microvision, Inc. |
| K990872 | SCLERAL PLUGS, 19 AND 20 GAUGE | Jul 13, 1999 | Substantially Equivalent | Ophthalmic Consultants, Inc. |
| K945114 | VISITEC SCLERAL PLUG | Feb 23, 1995 | Substantially Equivalent | Visitec Co. |
| K925671 | DISPOSABLE SCLERAL PLUGS | Aug 02, 1993 | Substantially Equivalent | O.R. Specialties, Inc. |
| K880953 | ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG | May 13, 1988 | Substantially Equivalent | Advanced Surgical Products, Inc. |
| K880952 | PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS | May 13, 1988 | Substantially Equivalent | Advanced Surgical Products, Inc. |
| K871604 | MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS | Jun 12, 1987 | Substantially Equivalent | Advanced Surgical Products, Inc. |
| K854507 | STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS | Feb 07, 1986 | Substantially Equivalent | Storz Instrument Co. |
| K840693 | DISPOSABLE SCLERAL GLOBE PLUG | May 22, 1984 | Substantially Equivalent | Innovative Surgical Products, Inc. |
| K831193 | SCLERAL PLUG | Jun 30, 1983 | Substantially Equivalent | Medical Instrument Development Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.