510(k) K230951
- Device
- Terumo Injection Filter Needle (NF-3013RBKE05M)
- Applicant
- Terumo Europe N.V.
- 510(k) number
- K230951
- Product code
- QYM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-18
- Date received
- 2023-04-04
- Regulation
- 880.5570
- Classification name
- Ophthalmic Needle
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Liesbeth Decoster
- Address
- Interleuvenlaan 40 Leuven BE 3012 3012
FDA Registration Numbers#
- 9615588
- 9681387
- 9681413
- 3012552122
- 3012478173
- 3034676720
- 3005941719
Source Documents#
Other 510(k) Records For Product Code QYM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | Tsk Laboratory International Japan KK | 2024-10-23 |