Safety Pen Needle
K-Number: K210864 · 2022-02-17
Device Summary
Frequently Asked Questions
What is the Safety Pen Needle?
Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Sandstone Medical (Suzhou), Inc.. The 510(k) number is K210864.
When did Safety Pen Needle receive FDA 510(k) clearance?
Safety Pen Needle received FDA 510(k) clearance on 2022-02-17, under 510(k) number K210864.
Who is the listed applicant for Safety Pen Needle?
The FDA 510(k) record lists Sandstone Medical (Suzhou), Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Safety Pen Needle?
The FDA product code for Safety Pen Needle is FMI.
Other records listing Sandstone Medical (Suzhou), Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FMI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.