Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM(1/5')
FDA 510(k) K093109 · Novo Nordisk, Inc.
510(k) numberK093109
Submission
- Device name
- Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM(1/5')
- Applicant
- Novo Nordisk, Inc.
Princeton, NJ, US - Received
- October 1, 2009
- Decision date
- June 18, 2010
- 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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| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| 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 |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
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| 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 |
| 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 |
| K133738 | Novofine Plus 32G 4 MMFMI · Traditional | 05/21/2014SE |
| K123766 | Novopen Echo, a Dial a Dose Insulin Delivery PenFMF · Traditional | 08/15/2013SE |
| K090111 | Flexpen NeedleFMI · Traditional | 02/01/2010SE |
Questions and answers
When was Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM(1/5') cleared by the FDA?
Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM(1/5') (K093109) received a 510(k) decision of Substantially Equivalent on June 18, 2010, 260 days after the submission was received.
What is the product code of K093109?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.