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FDA 510(k)

STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES

K-Number: K052085 · 2005-10-14

ApplicantAsia-Med GmbH and CO KG
Decision Date2005-10-14
Product CodeMQX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Asia-Med GmbH and CO KG. It received FDA 510(k) clearance on 2005-10-14 under 510(k) number K052085. 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 STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES?

STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES is a medical device that received FDA 510(k) clearance on 2005-10-14. The listed applicant is Asia-Med GmbH and CO KG. The 510(k) number is K052085.

When did STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES receive FDA 510(k) clearance?

STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES received FDA 510(k) clearance on 2005-10-14, under 510(k) number K052085.

Who is the listed applicant for STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES?

The FDA 510(k) record lists Asia-Med GmbH and CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES?

The FDA product code for STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE 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 Asia-Med GmbH and CO KG 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.

K132896CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBEK031716SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPEK011808ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)

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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