HQX · Implant, Orbital, Extra-Ocular
Ophthalmic · 21 CFR 886.3340 · Class 2
Overview
| Product Code | HQX |
|---|---|
| Device Name | Implant, Orbital, Extra-Ocular |
| Regulation | 21 CFR 886.3340 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
Classification Rationale
Class II.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | Microvision, Inc. | Jan 8, 2003 | SESE |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | Nov 6, 1998 | SESE |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Fci Ophthalmics, Inc. | Sep 18, 1998 | SESE |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Fci Ophthalmics, Inc. | Oct 28, 1996 | SESE |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | Jun 5, 1996 | SESE |
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Storz Ophthalmics, Inc. | Mar 2, 1995 | SESE |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Visitec Co. | Jan 17, 1995 | SESE |
| K902308 | TAMCENAN OCULAR EXPLANTS AND BANDS | Tamcenan Corp. | Jun 19, 1990 | SESE |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | Oculo Plastik, Inc. | May 22, 1990 | SESE |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | Oculo Plastik, Inc. | May 18, 1990 | SESE |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | May 15, 1990 | SESE |
| K900928 | COX MALAR EMINENCE IMPLANTS | Oculo Plastik, Inc. | May 15, 1990 | SESE |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | May 15, 1990 | SESE |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Porex Medical | Feb 27, 1987 | SESE |
| K832481 | SCLERAL BUCKLING IMPLANTS DIF/TYPES | Storz Instrument Co. | Sep 20, 1983 | SESE |
| K800140 | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | Dow Corning Corp. Healthcare Industries Materials | Mar 3, 1980 | SESE |
Top Applicants
- Oculo Plastik, Inc. — 5 clearances
- Fci Ophthalmics, Inc. — 2 clearances
- Bio-Vascular, Inc. — 1 clearance
- Dow Corning Corp. Healthcare Industries Materials — 1 clearance
- Microvision, Inc. — 1 clearance
