Pen Injector

FDA 510(k) K240774 · Wuxi Nest Biotechnology Co., Ltd.

Substantially Equivalent

510(k) numberK240774

Submission

Device name
Pen Injector
Applicant
Wuxi Nest Biotechnology Co., Ltd.
Wuxi, CN
Received
March 21, 2024
Decision date
June 18, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FMF – Syringe, Piston
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

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More from Instylla, Inc.

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K240961Disposable Pen Injector AssemblyFMF · Traditional 08/15/2024SE
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K210440Disposable Sampler Inactivated Transport Media, Nest ITMQBD · Traditional 09/20/2021SE

Questions and answers

When was Pen Injector cleared by the FDA?

Pen Injector (K240774) received a 510(k) decision of Substantially Equivalent on June 18, 2024, 89 days after the submission was received.

What is the product code of K240774?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.