FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
K Number: K242956
·
Decision Oct 25, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
- K Number
- K242956
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ocuject, LLC
- Date Received
- September 25, 2024
- Decision Date
- October 25, 2024
- Product Code
- QNS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QNS | Low Dead Space Needle, Single Lumen, Hypodermic | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QNS), ordered by most recent decision date.
STERiJECT Low Dead Space, STERiJECT The Invisible Needle
FDA 510(k)
FDA Class 2
·General Hospital
EZ-Injec LDV Sterile Safety Needle
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Ocuject, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Nov 27, 2023 | Substantially Equivalent |
| K230959 | VitreJect® Needle; OcuSafe® Needle | Sep 14, 2023 | Substantially Equivalent |
| K230372 | VitreJect Syringe | Sep 8, 2023 | Substantially Equivalent |
| K212544 | MiniLoad Syringe | Oct 13, 2021 | Substantially Equivalent |
| K212805 | SteriCap Mini Needle and Standard Needles | Sep 30, 2021 | Substantially Equivalent |
| K202432 | MiniLoad Syringe | Feb 19, 2021 | Substantially Equivalent |
| K170768 | Mini Needle | Jul 10, 2017 | Substantially Equivalent |