Product code HQX
- Device name
- Implant, Orbital, Extra-Ocular
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.3340
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | Microvision, Inc. | 2003-01-08 |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | 1998-11-06 |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Fci Ophthalmics, Inc. | 1998-09-18 |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Fci Ophthalmics, Inc. | 1996-10-28 |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | 1996-06-05 |
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Storz Ophthalmics, Inc. | 1995-03-02 |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Visitec Co. | 1995-01-17 |
| K902308 | TAMCENAN OCULAR EXPLANTS AND BANDS | Tamcenan Corp. | 1990-06-19 |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | Oculo Plastik, Inc. | 1990-05-22 |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | Oculo Plastik, Inc. | 1990-05-18 |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 |
| K900928 | COX MALAR EMINENCE IMPLANTS | Oculo Plastik, Inc. | 1990-05-15 |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Porex Medical | 1987-02-27 |
| K832481 | SCLERAL BUCKLING IMPLANTS DIF/TYPES | Storz Instrument Co. | 1983-09-20 |
| K800140 | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | Dow Corning Corp. Healthcare Industries Materials | 1980-03-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08717872014555 | Scleral Buckling Product Style 505T, 5.0mm Round Tunel Sponge | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2020-11-16 |
| 08717872014661 | Scleral Buckling Product Style 519G, 3.2mm x 7.5mm Grooved Sponge | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2020-11-16 |
| 08717872014487 | Scleral Buckling Product Style 106, Meridional Implant - 10.5mm | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 2020-11-16 |
| 10818255011439 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011521 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011491 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011460 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011453 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011446 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011422 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011415 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011392 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011378 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011330 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011323 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011231 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011224 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011217 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011200 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011194 | NA | MICROVISION, INC. | 2017-12-22 |
| 10818255011385 | NA | MICROVISION, INC. | 2017-12-22 |
| 10850510007139 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007115 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007108 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007092 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007061 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007054 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007047 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007030 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |
| 10850510007016 | MIRA IMEX Scleral Buckling Component | MIRA, INC. | 2016-09-24 |