HQX — Implant, Orbital, Extra-Ocular Class II
FDA product code HQX covers "Implant, Orbital, Extra-Ocular", a Class II medical device regulated under 21 CFR 886.3340. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HQX
- Device Class
- Class II
- Regulation Number
- 886.3340
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K023481 | microvision | MICROVISION SCLERAL BUCKLING COMPONENTS | January 8, 2003 |
| K983581 | bio-vascular | OCU-GUARD AND OCU-GUARD SUPPLE | November 6, 1998 |
| K980816 | fci ophthalmics | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | September 18, 1998 |
| K963219 | fci ophthalmics | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND S | October 28, 1996 |
| K950806 | mira | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | June 5, 1996 |
| K950599 | storz ophthalmics | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | March 2, 1995 |
| K945172 | visitec | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | January 17, 1995 |
| K902308 | tamcenan | TAMCENAN OCULAR EXPLANTS AND BANDS | June 19, 1990 |
| K901002 | oculo plastik | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | May 22, 1990 |
| K900929 | oculo plastik | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | May 18, 1990 |
| K900930 | oculo plastik | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | May 15, 1990 |
| K900928 | oculo plastik | COX MALAR EMINENCE IMPLANTS | May 15, 1990 |
| K900927 | oculo plastik | CODERE-DURETTE ORBITAL FLOOR IMPLANT | May 15, 1990 |
| K863946 | porex medical | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | February 27, 1987 |
| K832481 | storz instrument | SCLERAL BUCKLING IMPLANTS DIF/TYPES | September 20, 1983 |
| K800140 | dow corning corp. healthcare industries materials | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | March 3, 1980 |