FDA 510(k)

BIOMATE STERILE ACUPUNCTURE NEEDLE

K-Number: K103061 · 2011-06-20

ApplicantBiomate Medical Devices Technology Co., Ltd.

Decision Date2011-06-20

Product CodeMQX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BIOMATE STERILE ACUPUNCTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Biomate Medical Devices Technology Co., Ltd.. It received FDA 510(k) clearance on 2011-06-20 under 510(k) number K103061. The device is classified under product code MQX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMATE STERILE ACUPUNCTURE NEEDLE?

BIOMATE STERILE ACUPUNCTURE NEEDLE is a medical device that received FDA 510(k) clearance on 2011-06-20. The listed applicant is Biomate Medical Devices Technology Co., Ltd.. The 510(k) number is K103061.

When did BIOMATE STERILE ACUPUNCTURE NEEDLE receive FDA 510(k) clearance?

BIOMATE STERILE ACUPUNCTURE NEEDLE received FDA 510(k) clearance on 2011-06-20, under 510(k) number K103061.

Who is the listed applicant for BIOMATE STERILE ACUPUNCTURE NEEDLE?

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

What is the FDA product code for BIOMATE STERILE ACUPUNCTURE NEEDLE?

The FDA product code for BIOMATE STERILE ACUPUNCTURE NEEDLE is MQX.

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Other records listing Biomate Medical Devices Technology Co., Ltd. as applicant

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Related Devices (Code: MQX)

K162566AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd.K132896CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBEAsia-Med GmbH and CO KG K111392WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)Woojeon Company K092240ACUPUNCTURE NEEDLESHaenglim Seowon Medical Co.K090199JIAJIAN ACUPUNCTURE NEEDLEWuxi Jiajian Medical Instrument Co., Ltd.K090910HANSO ACUPUNCTURE NEEDLEHansol Medical Co.

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.