EZ-Injec LDV Sterile Safety Needle
FDA 510(k) clearance K210444 · decided 2021-02-16
Clearance details
- K-number
- K210444
- Device name
- EZ-Injec LDV Sterile Safety Needle
- Applicant
- Poonglim Pharmatech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-16
- Decision date
- 2021-02-16
- Days to decision
- 0 days
- Clearance type
- Traditional
- Product code
- QNS
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Gunsan, KR
- 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 |
|---|---|---|
| LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (K242956) | Ocuject, LLC | 2024-10-25 |
| STERiJECT Low Dead Space, STERiJECT The Invisible Needle (K231734) | Tsk Laboratory International Japan KK | 2024-03-08 |
Recalls involving this device
No recalls on record reference this clearance.