Decision Date2016-09-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
CareSens Pen Needle, Softip Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Yidobio, Inc.. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K160575. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CareSens Pen Needle, Softip Pen Needle?
CareSens Pen Needle, Softip Pen Needle is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Yidobio, Inc.. The 510(k) number is K160575.
When did CareSens Pen Needle, Softip Pen Needle receive FDA 510(k) clearance?
CareSens Pen Needle, Softip Pen Needle received FDA 510(k) clearance on 2016-09-07, under 510(k) number K160575.
Who is the listed applicant for CareSens Pen Needle, Softip Pen Needle?
The FDA 510(k) record lists Yidobio, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CareSens Pen Needle, Softip Pen Needle?
The FDA product code for CareSens Pen Needle, Softip Pen Needle is FMI.
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.
K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.
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.