FDA 510(k)

KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE

K-Number: K980471 · 1998-04-09

ApplicantAmerican Institute of Koryo Hand Therapy

Decision Date1998-04-09

Product CodeMQX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is American Institute of Koryo Hand Therapy. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K980471. 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 KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE?

KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is American Institute of Koryo Hand Therapy. The 510(k) number is K980471.

When did KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE receive FDA 510(k) clearance?

KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE received FDA 510(k) clearance on 1998-04-09, under 510(k) number K980471.

Who is the listed applicant for KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE?

The FDA 510(k) record lists American Institute of Koryo Hand Therapy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE?

The FDA product code for KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Institute of Koryo Hand Therapy as applicant

K980472KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE K980470KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE K980469KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE K974527KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE

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

View on FDA Database →

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