Safety Pen Needle for Single Use, Insulin Pen Needles
K-Number: K212514 · 2022-04-29
Device Summary
Frequently Asked Questions
What is the Safety Pen Needle for Single Use, Insulin Pen Needles?
Safety Pen Needle for Single Use, Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K212514.
When did Safety Pen Needle for Single Use, Insulin Pen Needles receive FDA 510(k) clearance?
Safety Pen Needle for Single Use, Insulin Pen Needles received FDA 510(k) clearance on 2022-04-29, under 510(k) number K212514.
Who is the listed applicant for Safety Pen Needle for Single Use, Insulin Pen Needles?
The FDA 510(k) record lists Berpu Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles?
The FDA product code for Safety Pen Needle for Single Use, Insulin Pen Needles is FMI.
Related Clinical Trials
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.
Other records listing Berpu Medical Technology 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.