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FDA 510(k)

VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH

K-Number: K111424 · 2011-07-29

ApplicantMedpro Safety Products, Inc.
Decision Date2011-07-29
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Medpro Safety Products, Inc.. It received FDA 510(k) clearance on 2011-07-29 under 510(k) number K111424. 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 VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH?

VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Medpro Safety Products, Inc.. The 510(k) number is K111424.

When did VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH receive FDA 510(k) clearance?

VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH received FDA 510(k) clearance on 2011-07-29, under 510(k) number K111424.

Who is the listed applicant for VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH?

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

What is the FDA product code for VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH?

The FDA product code for VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH 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 Medpro Safety Products, Inc. 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.

K102010VACUETTE PREMIUM SAFETY BLOOD COLLECTION SETK072602VACUETTE PREMIUM SAFETY NEEDLE SYSTEM

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

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