FDA 510(k)

U&U STERILE HYPODERMIC NEEDLE

K-Number: K132552 · 2013-11-13

ApplicantU&U Medical Technology Co, Ltd.

Decision Date2013-11-13

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

U&U STERILE HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2013-11-13 under 510(k) number K132552. 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 U&U STERILE HYPODERMIC NEEDLE?

U&U STERILE HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 2013-11-13. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K132552.

When did U&U STERILE HYPODERMIC NEEDLE receive FDA 510(k) clearance?

U&U STERILE HYPODERMIC NEEDLE received FDA 510(k) clearance on 2013-11-13, under 510(k) number K132552.

Who is the listed applicant for U&U STERILE HYPODERMIC NEEDLE?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U STERILE HYPODERMIC NEEDLE?

The FDA product code for U&U STERILE HYPODERMIC 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing U&U Medical Technology Co, Ltd. as applicant

K181508U&U Blood Collection Sets K171823U&U Indicator tape and strip K160855U&U Enteral Syringe K152808U&U Insulin Syringe with/without Safety Retractable Device

Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed 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.