DISPOSABLE SCLERAL PLUGS
FDA 510(k) clearance K925671 · decided 1993-08-02
Clearance details
- K-number
- K925671
- Device name
- DISPOSABLE SCLERAL PLUGS
- Applicant
- O.R. Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-10
- Decision date
- 1993-08-02
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- LXP
- Device class
- 2
- Regulation number
- 886.4155
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tuscaloosa, AL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.