Sungshim Insulin Pen Needle
K-Number: K152334 · 2016-03-17
Device Summary
Frequently Asked Questions
What is the Sungshim Insulin Pen Needle?
Sungshim Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Sung Shim Medicare Co., Ltd.. The 510(k) number is K152334.
When did Sungshim Insulin Pen Needle receive FDA 510(k) clearance?
Sungshim Insulin Pen Needle received FDA 510(k) clearance on 2016-03-17, under 510(k) number K152334.
Who is the listed applicant for Sungshim Insulin Pen Needle?
The FDA 510(k) record lists Sung Shim Medicare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sungshim Insulin Pen Needle?
The FDA product code for Sungshim Insulin Pen Needle is FMI.
Other records listing Sung Shim Medicare Co., Ltd. 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.