FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NovoFine® Plus
K Number: K231255
·
Decision Aug 25, 2023
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
14
Review Days
116
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Basic Information
- Device Name
- NovoFine® Plus
- K Number
- K231255
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novo Nordisk, Inc.
- Date Received
- May 1, 2023
- Decision Date
- August 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 Novo Nordisk, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210258 | NovoFine | Jun 23, 2021 | Substantially Equivalent |
| K202005 | NovoFine Plus 32G Tip x 4 mm | Dec 19, 2020 | Substantially Equivalent |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Dec 17, 2018 | Substantially Equivalent |
| K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | Jan 17, 2018 | Substantially Equivalent |
| K162602 | NovoPen Echo | Oct 18, 2016 | Substantially Equivalent |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Jul 31, 2015 | Substantially Equivalent |
| K133738 | NOVOFINE PLUS 32G 4 MM | May 21, 2014 | Substantially Equivalent |
| K123766 | NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN | Aug 15, 2013 | Substantially Equivalent |
| K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | Jun 18, 2010 | Substantially Equivalent |
| K090111 | FLEXPEN NEEDLE | Feb 1, 2010 | Substantially Equivalent |