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Maeda Silver Acupuncture Needle

by Maeda Toyokichi Shoten

510(k) K021904

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021904 Date14 Aug 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQX
Device Class
Class II
Regulation
21 CFR Part 880.5580
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Maeda Silver Acupuncture Needle is a sterile, disposable device used by qualified acupuncture practitioners to pierce the skin for therapeutic purposes. It is a manual instrument that does not utilize electronic or automated components.

The device is supplied as a single-use needle and is classified under regulation number 880.5580 with product code MQX. It received FDA 510(k) clearance (K021904) on August 14, 2002, and is designated for use in general hospital settings.

Other devices from Maeda Toyokichi Shoten

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Maeda Silver Acupuncture Needle used for?

    The Maeda Silver Acupuncture Needle is used by qualified acupuncture practitioners to pierce the skin for therapeutic purposes. It is a manual instrument without electronic or automated components, designed for general hospital settings as indicated in its regulatory filing.

  • Is the Maeda Silver Acupuncture Needle sterile and single-use?

    Yes, the device is supplied as a sterile, single-use needle. This means it is intended for one-time use only and should be discarded after each procedure to maintain sterility and prevent cross-contamination.

  • What regulatory information applies to the Maeda Silver Acupuncture Needle?

    The device is classified under regulation number 880.5580 with product code MQX and received FDA 510(k) clearance (K021904) on August 14, 2002. It was found substantially equivalent to a predicate device and is designated for use in general hospital settings.