RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
FDA 510(k) clearance K963219 · decided 1996-10-28
Clearance details
- K-number
- K963219
- Device name
- RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
- Applicant
- Fci Ophthalmics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-16
- Decision date
- 1996-10-28
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- HQX
- Device class
- 2
- Regulation number
- 886.3340
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Marshfield Hills, MA, 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 |
|---|---|---|
| MICROVISION SCLERAL BUCKLING COMPONENTS (K023481) | Microvision, Inc. | 2003-01-08 |
| OCU-GUARD AND OCU-GUARD SUPPLE (K983581) | Bio-Vascular, Inc. | 1998-11-06 |
| RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES (K980816) | Fci Ophthalmics, Inc. | 1998-09-18 |
| SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (K950806) | Mira, Inc. | 1996-06-05 |
| STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599) | Storz Ophthalmics, Inc. | 1995-03-02 |
| VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (K945172) | Visitec Co. | 1995-01-17 |
| TAMCENAN OCULAR EXPLANTS AND BANDS (K902308) | Tamcenan Corp. | 1990-06-19 |
| O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES (K901002) | Oculo Plastik, Inc. | 1990-05-22 |
| PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL (K900929) | Oculo Plastik, Inc. | 1990-05-18 |
| COX MALAR EMINENCE IMPLANTS (K900928) | Oculo Plastik, Inc. | 1990-05-15 |
| CODERE-DURETTE ORBITAL FLOOR IMPLANT (K900927) | Oculo Plastik, Inc. | 1990-05-15 |
| SPIVEY-ALLEN ORBITAL FLOOR IMPLANT (K900930) | Oculo Plastik, Inc. | 1990-05-15 |
Recalls involving this device
No recalls on record reference this clearance.