Terumo Injection Filter Needle (NF-3013RBKE05M)
FDA 510(k) clearance K230951 · decided 2023-10-18
Clearance details
- K-number
- K230951
- Device name
- Terumo Injection Filter Needle (NF-3013RBKE05M)
- Applicant
- Terumo Europe N.V.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-04
- Decision date
- 2023-10-18
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- QYM
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Terumo Europe N.V.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (K242073) | Tsk Laboratory International Japan KK | 2024-10-23 |
Recalls involving this device
No recalls on record reference this clearance.