LXP
10 FDA 510(k) clearances · Product code
96 daysmedian time to decision
265 days90th percentile
10clearances measured
FDA profile
- Official device name
- Plug, Scleral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4155
- Medical specialty
- Ophthalmic
- FDA definition
- Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SCLERAL PLUGS, 19 AND 20 GAUGE (K022186) | Microvision, Inc. | 2003-02-26 |
| SCLERAL PLUGS, 19 AND 20 GAUGE (K990872) | Ophthalmic Consultants, Inc. | 1999-07-13 |
| VISITEC SCLERAL PLUG (K945114) | Visitec Co. | 1995-02-23 |
| DISPOSABLE SCLERAL PLUGS (K925671) | O.R. Specialties, Inc. | 1993-08-02 |
| PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS (K880952) | Advanced Surgical Products, Inc. | 1988-05-13 |
| ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG (K880953) | Advanced Surgical Products, Inc. | 1988-05-13 |
| MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS (K871604) | Advanced Surgical Products, Inc. | 1987-06-12 |
| STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS (K854507) | Storz Instrument Co. | 1986-02-07 |
| DISPOSABLE SCLERAL GLOBE PLUG (K840693) | Innovative Surgical Products, Inc. | 1984-05-22 |
| SCLERAL PLUG (K831193) | Medical Instrument Development Laboratories, Inc. | 1983-06-30 |
Track LXP automatically
Every clearance here is in the API, with alerts when new ones post.