FDA 510(k)

BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA

K-Number: K102328 · 2011-05-13

ApplicantShandong Weigao Group Medical Polymer Co., Ltd.

Decision Date2011-05-13

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Weigao Group Medical Polymer Co., Ltd.. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K102328. 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 BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA?

BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Shandong Weigao Group Medical Polymer Co., Ltd.. The 510(k) number is K102328.

When did BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA receive FDA 510(k) clearance?

BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA received FDA 510(k) clearance on 2011-05-13, under 510(k) number K102328.

Who is the listed applicant for BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA?

The FDA 510(k) record lists Shandong Weigao Group Medical Polymer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA?

The FDA product code for BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA 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 Shandong Weigao Group Medical Polymer Co., Ltd. as applicant

K212207Sterile Hypodermic Syringe for Single Use K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use K102741ENTERAL FEEDING BAG AND SETS K081241WEIGAO EMPTY CARTRIDGE SYRINGE K072739JIERUI SYRINGES AND NEEDLES K073127BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G

View all 7 devices →

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.