FDA 510(k)

ACUMASTER BRAND ACUPUNCTURE NEEDLE

K-Number: K991508 · 1999-08-27

Decision Date1999-08-27

Product CodeMQX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ACUMASTER BRAND ACUPUNCTURE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Helio Medical Supplies, Inc.. It received FDA 510(k) clearance on 1999-08-27 under 510(k) number K991508. 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 ACUMASTER BRAND ACUPUNCTURE NEEDLE?

ACUMASTER BRAND ACUPUNCTURE NEEDLE is a medical device that received FDA 510(k) clearance on 1999-08-27. The listed applicant is Helio Medical Supplies, Inc.. The 510(k) number is K991508.

When did ACUMASTER BRAND ACUPUNCTURE NEEDLE receive FDA 510(k) clearance?

ACUMASTER BRAND ACUPUNCTURE NEEDLE received FDA 510(k) clearance on 1999-08-27, under 510(k) number K991508.

Who is the listed applicant for ACUMASTER BRAND ACUPUNCTURE NEEDLE?

The FDA 510(k) record lists Helio Medical Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUMASTER BRAND ACUPUNCTURE NEEDLE?

The FDA product code for ACUMASTER BRAND 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 Helio Medical Supplies, Inc. as applicant

K080221EA STIMULATOR K072778BRIO ACUPUNCTURE NEEDLES K062448LYRA ACUPUNCTURE NEEDLES K052723SEVEN STAR NEEDLE K050295PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES K043277C&G ACUPUNCTURE NEEDLE

View all 12 devices →

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.