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SMC Acupuncture Needle

by Smc Intl., Inc.

510(k) K141473

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 NumberK141473 Date1 Aug 2014ClearedStatusActive

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  • Withdrawn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, 22 Sep 2026

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

The device is an acupuncture needle, a single-use needle used in acupuncture procedures. It is made of surgical stainless steel with a precision-ground tip for clean insertion and a spring-style handle.

It is supplied in a 1,000-count blister pack, sterilized for single use, and authorized under FDA 510(k) clearance (K141473) as a Class II device. The needle is intended for general hospital use and is manufactured under strict quality controls covering raw materials, production, surface polish, and sterilization.

Questions

AI-generated answers, 22 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 SMC Acupuncture Needle used for?

    The SMC Acupuncture Needle is used in acupuncture procedures for general hospital use, designed for clean insertion due to its precision-ground tip and surgical stainless steel construction.

  • How is the SMC Acupuncture Needle supplied and sterilized?

    It is supplied in a 1,000-count blister pack and sterilized for single use, ensuring each needle is ready for immediate clinical application without reprocessing.

  • Is the SMC Acupuncture Needle reusable or single-use?

    The device is explicitly designed for single use only, as indicated by its sterilized blister pack labeling and intended use in acupuncture procedures where cross-contamination must be avoided.

  • What materials and design features does the SMC Acupuncture Needle have?

    It is made of surgical stainless steel with a precision-ground tip for clean insertion and features a spring-style handle to aid practitioner control during acupuncture procedures.

  • What regulatory pathway authorized the SMC Acupuncture Needle?

    The SMC Acupuncture Needle received FDA 510(k) clearance (K141473) as a Class II device, demonstrating substantial equivalence to a legally marketed predicate device.