FDA 510(k)

FISTULOK FISTULA NEEDLE PROTECTION

K-Number: K010958 · 2001-05-18

Decision Date2001-05-18

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FISTULOK FISTULA NEEDLE PROTECTION is the device name listed in this FDA 510(k) record. The listed applicant is Diasol, Inc.. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010958. 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 FISTULOK FISTULA NEEDLE PROTECTION?

FISTULOK FISTULA NEEDLE PROTECTION is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Diasol, Inc.. The 510(k) number is K010958.

When did FISTULOK FISTULA NEEDLE PROTECTION receive FDA 510(k) clearance?

FISTULOK FISTULA NEEDLE PROTECTION received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010958.

Who is the listed applicant for FISTULOK FISTULA NEEDLE PROTECTION?

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

What is the FDA product code for FISTULOK FISTULA NEEDLE PROTECTION?

The FDA product code for FISTULOK FISTULA NEEDLE PROTECTION is FMI.

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Other records listing Diasol, Inc. as applicant

K020231DIASOL-ADDITIVES K020230DIASOL-BICARB K011004NEEDLELOK HYPODERMIC NEEDLE PROTECTION K011003SAFESTING AND SAFESTING HUB K993187SHELLY PROTECTED AV FISTULA NEEDLE K992999DAISY PROTECTED SCALP VEIN SET

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.