FDA 510(k)
FDA class 2
Substantially Equivalent
🇵🇭 Philippines
Terumo SurGuard 3 Safety Hypodermic Needle
K Number: K152362
·
Decision Oct 16, 2015
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
57
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Basic Information
- Device Name
- Terumo SurGuard 3 Safety Hypodermic Needle
- K Number
- K152362
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo (Philippines) Corporation
- Date Received
- August 20, 2015
- Decision Date
- October 16, 2015
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Terumo (Philippines) Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K133280 | TERUMO SURFLO I.V. CATHETER | Jun 12, 2014 | Substantially Equivalent |
| K121607 | TERUMO(R) NEEDLE | Nov 8, 2012 | Substantially Equivalent |
| K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE | Aug 28, 2012 | Substantially Equivalent |
| K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE | Mar 5, 2012 | Substantially Equivalent |