FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
K Number: K222852
·
Decision May 25, 2023
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
34
Review Days
246
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Basic Information
- Device Name
- Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
- K Number
- K222852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- September 21, 2022
- Decision Date
- May 25, 2023
- 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 Nipro Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253047 | PRESSONE | Mar 24, 2026 | Substantially Equivalent |
| K260533 | ELISIO-H | Mar 19, 2026 | Substantially Equivalent |
| K212677 | aboNT SYRINGE | Apr 15, 2022 | Substantially Equivalent |
| K190037 | Cronus HP PTA Balloon Catheter | Oct 24, 2019 | Substantially Equivalent |
| K191359 | Nipro Syringe | Oct 9, 2019 | Substantially Equivalent |
| K182940 | Surdial DX Hemodialysis System | Jul 19, 2019 | Substantially Equivalent |
| K173029 | Nipro Syringe | Mar 30, 2018 | Substantially Equivalent |
| K161681 | Nipro SafeTouch IV Catheter | Mar 8, 2017 | Substantially Equivalent |
| K160444 | FB-U Hemodialyzer | Feb 8, 2017 | Substantially Equivalent |
| K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | Jan 14, 2016 | Substantially Equivalent |