NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
FDA 510(k) K173479 · Novo Nordisk, Inc.
510(k) numberK173479
Submission
- Device name
- NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
- Applicant
- Novo Nordisk, Inc.
Plainsboro, NJ, US - Received
- November 13, 2017
- Decision date
- January 17, 2018
- 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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| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
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More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231255 | NovoFine® PlusFMI · Special | 08/25/2023SE |
| K210258 | NovoFineFMI · Traditional | 06/23/2021SE |
| K202005 | NovoFine Plus 32G Tip x 4 mmFMI · Traditional | 12/19/2020SE |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)FMF · Traditional | 12/17/2018SE |
| K162602 | NovoPen EchoFMF · Special | 10/18/2016SE |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)FMF · Special | 07/31/2015SE |
| K133738 | Novofine Plus 32G 4 MMFMI · Traditional | 05/21/2014SE |
| 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 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) cleared by the FDA?
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (K173479) received a 510(k) decision of Substantially Equivalent on January 17, 2018, 65 days after the submission was received.
What is the product code of K173479?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.