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FDA 510(k)

ACUGLIDE BRAND ACUPUNCTURE NEEDLES

K-Number: K012583 · 2001-12-11

ApplicantHelio Medical Supplies, Inc.
Decision Date2001-12-11
Product CodeMQX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACUGLIDE BRAND ACUPUNCTURE NEEDLES 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 2001-12-11 under 510(k) number K012583. 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 ACUGLIDE BRAND ACUPUNCTURE NEEDLES?

ACUGLIDE BRAND ACUPUNCTURE NEEDLES is a medical device that received FDA 510(k) clearance on 2001-12-11. The listed applicant is Helio Medical Supplies, Inc.. The 510(k) number is K012583.

When did ACUGLIDE BRAND ACUPUNCTURE NEEDLES receive FDA 510(k) clearance?

ACUGLIDE BRAND ACUPUNCTURE NEEDLES received FDA 510(k) clearance on 2001-12-11, under 510(k) number K012583.

Who is the listed applicant for ACUGLIDE BRAND ACUPUNCTURE NEEDLES?

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 ACUGLIDE BRAND ACUPUNCTURE NEEDLES?

The FDA product code for ACUGLIDE BRAND ACUPUNCTURE NEEDLES is MQX.

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Other records listing Helio Medical Supplies, 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.

K080221EA STIMULATORK072778BRIO ACUPUNCTURE NEEDLESK062448LYRA ACUPUNCTURE NEEDLESK052723SEVEN STAR NEEDLEK050295PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLESK043277C&G ACUPUNCTURE NEEDLE

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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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