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FDA 510(k)

CLICKFINE AUTOPROTECT PEN NEEDLE

K-Number: K131123 · 2013-07-05

ApplicantYpsomed AG
Decision Date2013-07-05
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLICKFINE AUTOPROTECT PEN NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Ypsomed AG. It received FDA 510(k) clearance on 2013-07-05 under 510(k) number K131123. 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 CLICKFINE AUTOPROTECT PEN NEEDLE?

CLICKFINE AUTOPROTECT PEN NEEDLE is a medical device that received FDA 510(k) clearance on 2013-07-05. The listed applicant is Ypsomed AG. The 510(k) number is K131123.

When did CLICKFINE AUTOPROTECT PEN NEEDLE receive FDA 510(k) clearance?

CLICKFINE AUTOPROTECT PEN NEEDLE received FDA 510(k) clearance on 2013-07-05, under 510(k) number K131123.

Who is the listed applicant for CLICKFINE AUTOPROTECT PEN NEEDLE?

The FDA 510(k) record lists Ypsomed AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLICKFINE AUTOPROTECT PEN NEEDLE?

The FDA product code for CLICKFINE AUTOPROTECT PEN NEEDLE 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.

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Other records listing Ypsomed AG 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.

K243901SmartPilot YpsoMate NS-A2.25K171984Clickfine Pen Needle, Penfine Classic Pen NeedleK163400Orbit InserterK150921Orbit Infusion SetK131125CLICKFINE PEN NEEDLEK130468ORBIT INFUSION SET

View all 10 devices →

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.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.

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.

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