Easydrip Pen Needle, Easydrip Plus Pen Needle
K-Number: K193422 · 2021-02-02
Device Summary
Frequently Asked Questions
What is the Easydrip Pen Needle, Easydrip Plus Pen Needle?
Easydrip Pen Needle, Easydrip Plus Pen Needle is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is Sandstone Medical (Suzhou), Inc.. The 510(k) number is K193422.
When did Easydrip Pen Needle, Easydrip Plus Pen Needle receive FDA 510(k) clearance?
Easydrip Pen Needle, Easydrip Plus Pen Needle received FDA 510(k) clearance on 2021-02-02, under 510(k) number K193422.
Who is the listed applicant for Easydrip Pen Needle, Easydrip Plus 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 Easydrip Pen Needle, Easydrip Plus Pen Needle?
The FDA product code for Easydrip Pen Needle, Easydrip Plus 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.