Scleral Plugs, 19 and 20 Gauge
FDA 510(k) K990872 · Ophthalmic Consultants, Inc.
510(k) numberK990872
Submission
- Device name
- Scleral Plugs, 19 and 20 Gauge
- Applicant
- Ophthalmic Consultants, Inc.
Tooele, UT, US - Received
- March 16, 1999
- Decision date
- July 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXP – Plug, Scleral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4155
- Specialty
- Ophthalmic
Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Other 510(k)s with product code LXP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022186 | Scleral Plugs, 19 and 20 GaugeLXP · Traditional | Microvision, Inc. | 02/26/2003SE |
| 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 |
More from Medical Instrument Development Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990292 | I/A (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack…HQE · Traditional | 11/19/1999SE |
Questions and answers
When was Scleral Plugs, 19 and 20 Gauge cleared by the FDA?
Scleral Plugs, 19 and 20 Gauge (K990872) received a 510(k) decision of Substantially Equivalent on July 13, 1999, 119 days after the submission was received.
What is the product code of K990872?
The FDA product code is LXP – Plug, Scleral, a Class II (moderate risk) device regulated under 21 CFR 886.4155.