FDA 510(k)

SEIRIN JR ACUPUNCTURE NEEDLES

K-Number: K970260 · 1997-02-10

Decision Date1997-02-10

Product CodeMQX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SEIRIN JR ACUPUNCTURE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Seirin-America, Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K970260. 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 SEIRIN JR ACUPUNCTURE NEEDLES?

SEIRIN JR ACUPUNCTURE NEEDLES is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Seirin-America, Inc.. The 510(k) number is K970260.

When did SEIRIN JR ACUPUNCTURE NEEDLES receive FDA 510(k) clearance?

SEIRIN JR ACUPUNCTURE NEEDLES received FDA 510(k) clearance on 1997-02-10, under 510(k) number K970260.

Who is the listed applicant for SEIRIN JR ACUPUNCTURE NEEDLES?

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

What is the FDA product code for SEIRIN JR ACUPUNCTURE NEEDLES?

The FDA product code for SEIRIN JR ACUPUNCTURE NEEDLES is MQX.

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Other records listing Seirin-America, Inc. as applicant

K970254SEIRIN PYONEX ACUPUNCTURE NEEDLES K963769SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES K962809SEIRIN ACUPUNCTURE NEEDLES

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 K103061BIOMATE STERILE ACUPUNCTURE NEEDLEBiomate Medical Devices Technology Co., Ltd.K092240ACUPUNCTURE NEEDLESHaenglim Seowon Medical Co.K090199JIAJIAN ACUPUNCTURE NEEDLEWuxi Jiajian Medical Instrument Co., 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.