Product code HQJ
- Device name
- Implant, Absorbable, (Scleral Buckling Methods)
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.3300
- 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 |
|---|---|---|---|
| K896350 | TITAN AIR SPECTACLE FRAME | Acces Intl. Eyewear | 1989-12-18 |
| K884362 | LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 |
| K875014 | LABTICIAN RETINAL IMPLANTS | Labtician Products, Inc. | 1988-02-26 |
| K831773 | MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK | Bcd Products, Inc. | 1983-08-16 |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | 1976-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00871321000174 | Grooved Part Thickness Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000334 | Oblong Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000327 | Oblong Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000310 | Scholda Partial Thickness | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000303 | Scholda Partial Thickness | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000280 | Partial Thickness Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000273 | Partial Thickness Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000266 | Partial Thickness Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000259 | Partial Thickness Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000242 | Grooved Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000228 | Grooved Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000211 | Grooved Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000204 | Grooved Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000198 | Grooved Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000181 | Grooved Part Thickness Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000013 | Oval Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000167 | Grooved Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000150 | Round Sponge 7.5mm x 50mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000143 | Round Sponge 7mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000136 | Round Tunnel Sponge 5mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000129 | 5.0mm Round Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000112 | Round Sponge 5mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000105 | Round Sponge 4mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000099 | 3.0mm Round Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000082 | Round Sponge 3mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000075 | Round Sponge 2.5mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000068 | Round Sponge 2mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000051 | Round Sponge 1.5mm | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000044 | Oval Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |
| 00871321000020 | Oval Sponge | Labtician Ophthalmics, Inc | 2026-10-01 |