Product code QYM
- Device name
- Ophthalmic Needle
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5570
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04573545740077 | STERiJECT OPHTHALMIC NEEDLE™ | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050083 | STERiJECT OPHTHALMIC NEEDLE™ | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050076 | STERiJECT OPHTHALMIC NEEDLE™ | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050069 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050052 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050045 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050038 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050021 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04571603050014 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04573545740107 | STERiJECT OPHTHALMIC NEEDLE™ | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04573545740060 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04573545740053 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04573545740046 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04573545740039 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04573545740022 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 04573545740015 | STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) | TSK LABORATORY INTERNATIONAL JAPAN K.K. | 2025-07-14 |
| 00855265008861 | VitreJect Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 00855265008038 | VitreJect Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 10855265008868 | VitreJect Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 00855265008892 | VitreJect Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 00855265008922 | VitreJect Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 00850040387377 | VitreJect-DL Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 00855265008915 | VitreJect Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 00855265008885 | VitreJect Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 00850040387360 | VitreJect-DL Ophthalmic Needle | Ocuject, LLC | 2025-02-28 |
| 05413206251223 | Terumo | Terumo Europe NV | 2023-10-27 |
| 35413206251224 | Terumo | Terumo Europe NV | 2023-10-27 |