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Sharp Brand Acupuncture Needles

by Tcm Supply Corp.

510(k) K000816

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 NumberK000816 Date4 May 2000ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

Sharp Brand Acupuncture Needles are single‑use acupuncture needles intended for insertion into the skin at specific points for therapeutic purposes. They are classified as Class II medical devices and identified in the FDA database as a Needle, Acupuncture, Single Use.

The needles are supplied sterile, for single‑use only, and were cleared through FDA 510(k) submission K000816 on May 4 2000. They carry product code MQX, are listed under device class 2, and are regulated for general hospital use.

Other devices from Tcm Supply Corp.

Questions

AI-generated answers, 24 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 are Sharp Brand Acupuncture Needles used for?

    Sharp Brand Acupuncture Needles are intended for insertion into the skin at specific acupuncture points to provide therapeutic treatment, as stated in their FDA 510(k) clearance for general hospital use.

  • Are Sharp Brand Acupuncture Needles sterile and for single use only?

    Yes, the needles are supplied sterile and are designated for single-use only, meaning they must be discarded after one procedure to prevent cross-contamination and ensure patient safety.

  • What is the regulatory pathway and clearance number for Sharp Brand Acupuncture Needles?

    Sharp Brand Acupuncture Needles received FDA 510(k) clearance under submission K000816 on May 4, 2000, and were found substantially equivalent to a legally marketed predicate device.

  • What product code and device class are assigned to Sharp Brand Acupuncture Needles?

    The needles are assigned product code MQX and are classified as Class II medical devices under the FDA regulation number 880.5580 for acupuncture needles, single use.