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FDA 510(k)

SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES

K-Number: K963769 · 1996-10-16

ApplicantSeirin-America, Inc.
Decision Date1996-10-16
Product CodeMQX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SEIRIN SPINEX INTRADERMAL 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 1996-10-16 under 510(k) number K963769. 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 SPINEX INTRADERMAL ACUPUNCTURE NEEDLES?

SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES is a medical device that received FDA 510(k) clearance on 1996-10-16. The listed applicant is Seirin-America, Inc.. The 510(k) number is K963769.

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

SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES received FDA 510(k) clearance on 1996-10-16, under 510(k) number K963769.

Who is the listed applicant for SEIRIN SPINEX INTRADERMAL 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 SPINEX INTRADERMAL ACUPUNCTURE NEEDLES?

The FDA product code for SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES is MQX.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Seirin-America, 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.

K970260SEIRIN JR ACUPUNCTURE NEEDLESK970254SEIRIN PYONEX ACUPUNCTURE NEEDLESK962809SEIRIN ACUPUNCTURE NEEDLES

Related Devices (Code: MQX)

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.

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 KGK111392WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)Woojeon CompanyK103061BIOMATE STERILE ACUPUNCTURE NEEDLEBiomate Medical Devices Technology Co., Ltd.K092240ACUPUNCTURE NEEDLESHaenglim Seowon Medical Co.K090199JIAJIAN ACUPUNCTURE NEEDLEWuxi Jiajian Medical Instrument Co., 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.

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