FDA 510(k)

PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES

K-Number: K061517 · 2006-11-22

Decision Date2006-11-22

Product CodeMQX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Prime Herbs Corporation. It received FDA 510(k) clearance on 2006-11-22 under 510(k) number K061517. 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 PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES?

PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Prime Herbs Corporation. The 510(k) number is K061517.

When did PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES receive FDA 510(k) clearance?

PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES received FDA 510(k) clearance on 2006-11-22, under 510(k) number K061517.

Who is the listed applicant for PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES?

The FDA 510(k) record lists Prime Herbs Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES?

The FDA product code for PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT 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.

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Other records listing Prime Herbs Corporation as applicant

K081720PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS

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.