QYM
- Product code
- QYM
- Device name
- Ophthalmic Needle
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5570
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242073 | 2024-10-23 | Tsk Laboratory International Japan KK | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Ne… | |
| K230951 | 2023-10-18 | Terumo Europe N.V. | Terumo Injection Filter Needle (NF-3013RBKE05M) |
Official FDA classification page: QYM
Classification and pathway per current FDA publications. Data from openFDA (CC0).