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Acuglide Brand Acupuncture Needles

by Helio Medical Supplies, Inc.

510(k) K012583

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 NumberK012583 Date11 Dec 2001ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

Acuglide Brand Acupuncture Needles are single-use acupuncture needles classified as Class II medical devices under regulation number 880.5580. They are substantially equivalent to predicate devices and have received FDA 510(k) clearance (K012583).

These needles are supplied in color-coded dispensers with 10 needles plus 2 guide tubes per dispenser, 30 pouches per box, and 300 needles per box. They are manufactured in the United States and intended for use in general hospital settings.

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See all devices from Helio Medical Supplies, Inc. →

Questions

AI-generated answers, 1 Oct 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 Acuglide Brand Acupuncture Needles used for?

    Acuglide Brand Acupuncture Needles are intended for use in general hospital settings as single-use acupuncture needles, classified as Class II medical devices under regulation number 880.5580.

  • How are Acuglide Brand Acupuncture Needles supplied and packaged?

    They are supplied in color-coded dispensers containing 10 needles plus 2 guide tubes per dispenser, with 30 pouches per box and a total of 300 needles per box.

  • Are Acuglide Brand Acupuncture Needles reusable or single-use?

    Acuglide Brand Acupuncture Needles are single-use devices, as explicitly stated in their description and classification, meaning they are intended for one-time use only.