Plug, Scleral
FDA product code LXP · Class II (moderate risk) · 21 CFR 886.4155 · Ophthalmic
Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
10510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022186 | Scleral Plugs, 19 and 20 GaugeLXP · Traditional | Microvision, Inc. | 02/26/2003SE |
| K990872 | Scleral Plugs, 19 and 20 GaugeLXP · Traditional | Ophthalmic Consultants, Inc. | 07/13/1999SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | Visitec Co. | 02/23/1995SE |
| K925671 | Disposable Scleral PlugsLXP · Traditional | O.R. Specialties, Inc. | 08/02/1993SE |
| K880953 | Advanced Surgical 19 & 20 Gauge Disp. Scleral PlugLXP · Traditional | Advanced Surgical Products, Inc. | 05/13/1988SE |
| K880952 | Prisma Disposable 19 and 20 Gauge Scleral PlugsLXP · Traditional | Advanced Surgical Products, Inc. | 05/13/1988SE |
| K871604 | MVS 19 and MVS 20 Gauge Scleral PlugsLXP · Traditional | Advanced Surgical Products, Inc. | 06/12/1987SE |
| K854507 | Storz MVS 19 & 20 Gauge Scleral PlugsLXP · Traditional | Storz Instrument Co. | 02/07/1986SE |
| K840693 | Disposable Scleral Globe PlugLXP · Traditional | Innovative Surgical Products, Inc. | 05/22/1984SE |
| K831193 | Scleral PlugLXP · Traditional | Medical Instrument Development Laboratories, Inc. | 06/30/1983SE |