FDA 510(k)

MODIFICATION OF JMS NEEDLES AND JMS SYRINGES

K-Number: K991904 · 1999-08-31

Decision Date1999-08-31

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF JMS NEEDLES AND JMS SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Jms Co., Ltd.. It received FDA 510(k) clearance on 1999-08-31 under 510(k) number K991904. 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 MODIFICATION OF JMS NEEDLES AND JMS SYRINGES?

MODIFICATION OF JMS NEEDLES AND JMS SYRINGES is a medical device that received FDA 510(k) clearance on 1999-08-31. The listed applicant is Jms Co., Ltd.. The 510(k) number is K991904.

When did MODIFICATION OF JMS NEEDLES AND JMS SYRINGES receive FDA 510(k) clearance?

MODIFICATION OF JMS NEEDLES AND JMS SYRINGES received FDA 510(k) clearance on 1999-08-31, under 510(k) number K991904.

Who is the listed applicant for MODIFICATION OF JMS NEEDLES AND JMS SYRINGES?

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

What is the FDA product code for MODIFICATION OF JMS NEEDLES AND JMS SYRINGES?

The FDA product code for MODIFICATION OF JMS NEEDLES AND JMS SYRINGES 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 Jms Co., Ltd. as applicant

K002352JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE K002394JMS APHERESIS NEEDLE SET ACCORDION TYPE K010406JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G K010410JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G K000845MODIFICATION TO JMS A.V. FISTULA NEEDLE SET K000843MODIFICATION TO JMS APHERESIS NEEDLE

View all 24 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.