Novofine Plus 32G 4 MM
FDA 510(k) K133738 · Novo Nordisk, Inc.
510(k) numberK133738
Submission
- Device name
- Novofine Plus 32G 4 MM
- Applicant
- Novo Nordisk, Inc.
Plainsboro, NJ, US - Received
- December 9, 2013
- Decision date
- May 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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| K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)FMI · Traditional | 01/17/2018SE |
| K162602 | NovoPen EchoFMF · Special | 10/18/2016SE |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)FMF · Special | 07/31/2015SE |
| K123766 | Novopen Echo, a Dial a Dose Insulin Delivery PenFMF · Traditional | 08/15/2013SE |
| K093109 | Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM(1/5')FMI · Traditional | 06/18/2010SE |
| K090111 | Flexpen NeedleFMI · Traditional | 02/01/2010SE |
Questions and answers
When was Novofine Plus 32G 4 MM cleared by the FDA?
Novofine Plus 32G 4 MM (K133738) received a 510(k) decision of Substantially Equivalent on May 21, 2014, 163 days after the submission was received.
What is the product code of K133738?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.