Disposable Scleral Plugs
FDA 510(k) K925671 · O.R. Specialties, Inc.
510(k) numberK925671
Submission
- Device name
- Disposable Scleral Plugs
- Applicant
- O.R. Specialties, Inc.
Tuscaloosa, AL, US - Received
- November 10, 1992
- Decision date
- August 2, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K990872 | Scleral Plugs, 19 and 20 GaugeLXP · Traditional | Ophthalmic Consultants, Inc. | 07/13/1999SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | Visitec Co. | 02/23/1995SE |
| 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 |
|---|---|---|
| K942607 | Laparoscopic Scissors (Disposable)GEI · Traditional | 07/06/1994SE |
| K923630 | Phaco Needles 1000-R & 1000-O NeedlesHQC · Traditional | 04/06/1994SE |
| K923887 | Jack's Vent TubesETD · Traditional | 02/19/1993SE |
| K923774 | Disposable EndoilluminatorEQH · Traditional | 10/19/1992SE |
| K922355 | Polly's Vitreous Scissors J-225-SHQE · Traditional | 08/18/1992SE |
| K922180 | Lewicky O.R.S. TubingKYG · Traditional | 07/02/1992SE |
| K914038 | Polly's Cutter J-225HQE · Traditional | 12/09/1991SE |
| K911932 | J105 James Surgical System I/A PackGZX · Traditional | 08/26/1991SE |
| K890195 | James Surgical System J1000HQE · Traditional | 08/03/1989SE |
| K891161 | Vitrectomy Pack #J120HQC · Traditional | 05/26/1989SE |
Questions and answers
When was Disposable Scleral Plugs cleared by the FDA?
Disposable Scleral Plugs (K925671) received a 510(k) decision of Substantially Equivalent on August 2, 1993, 265 days after the submission was received.
What is the product code of K925671?
The FDA product code is LXP – Plug, Scleral, a Class II (moderate risk) device regulated under 21 CFR 886.4155.