510(k) K230951
K230951 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "Terumo Injection Filter Needle (NF-3013RBKE05M)". The FDA issued a decision of Substantially Equivalent on October 18, 2023. The device falls under product code QYM (Ophthalmic Needle), a Class II device regulated under 21 CFR 880.5570. Terumo Europe N.V. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2023
- Date Received
- April 4, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmic Needle
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
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.