Ophthalmic Needle
The ophthalmic needle (product code QYM) is a Class 2 General Hospital device (regulation 880.5570) intended for intraocular injections, to be used by healthcare professionals to perform injections into the eye. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QYM
- Device Class
- FDA class 2
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | Oct 23, 2024 | Substantially Equivalent | Tsk Laboratory International Japan KK |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | Oct 18, 2023 | Substantially Equivalent | Terumo Europe N.V. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.