LXP — Plug, Scleral Class II
FDA product code LXP covers "Plug, Scleral", a Class II medical device regulated under 21 CFR 886.4155. Submissions are reviewed by the Ophthalmic panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LXP
- Device Class
- Class II
- Regulation Number
- 886.4155
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K022186 | microvision | SCLERAL PLUGS, 19 AND 20 GAUGE | February 26, 2003 |
| K990872 | ophthalmic consultants | SCLERAL PLUGS, 19 AND 20 GAUGE | July 13, 1999 |
| K945114 | visitec | VISITEC SCLERAL PLUG | February 23, 1995 |
| K925671 | o.r. specialties | DISPOSABLE SCLERAL PLUGS | August 2, 1993 |
| K880953 | advanced surgical products | ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG | May 13, 1988 |
| K880952 | advanced surgical products | PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS | May 13, 1988 |
| K871604 | advanced surgical products | MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS | June 12, 1987 |
| K854507 | storz instrument | STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS | February 7, 1986 |
| K840693 | innovative surgical products | DISPOSABLE SCLERAL GLOBE PLUG | May 22, 1984 |
| K831193 | medical instrument development laboratories | SCLERAL PLUG | June 30, 1983 |