STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
FDA 510(k) clearance K242073 · decided 2024-10-23
Clearance details
- K-number
- K242073
- Device name
- STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
- Applicant
- Tsk Laboratory International Japan KK
- Decision
- Substantially Equivalent
- Date received
- 2024-07-16
- Decision date
- 2024-10-23
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- QYM
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tochigi-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Terumo Injection Filter Needle (NF-3013RBKE05M) (K230951) | Terumo Europe N.V. | 2023-10-18 |
Recalls involving this device
No recalls on record reference this clearance.