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Seirin Jr Acupuncture Needles

by Seirin-America, Inc.

510(k) K970260

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 NumberK970260 Date10 Feb 1997ClearedStatusActive

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  • Withdrawn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.

The Seirin Jr Acupuncture Needles are classified as single-use acupuncture needles, designed for insertion into the skin at specific acupuncture points. These needles are intended for use in traditional acupuncture practices to stimulate nerve pathways and promote physiological balance. Constructed for precision and safety, they adhere to regulatory standards for sterile medical devices.

These needles are supplied in sterile, single-use packaging for clinical settings, including general hospitals and acupuncture clinics. They are classified as Class II devices under FDA regulations and have received a 510(k) clearance for substantial equivalence. Various gauge sizes and lengths are available, as indicated by the listed FEI numbers, ensuring compatibility with different patient needs and practitioner preferences. Storage should follow manufacturer guidelines to maintain sterility and integrity.

Other devices from Seirin-America, 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 the Seirin Jr Acupuncture Needles used for?

    The Seirin Jr Acupuncture Needles are intended for traditional acupuncture practices. They are inserted into specific acupuncture points on the skin to stimulate nerve pathways and promote physiological balance, helping practitioners achieve therapeutic effects.

  • Are these needles single-use or reusable?

    These needles are strictly single-use only. They come in sterile packaging designed for clinical settings, ensuring safety and compliance with medical device regulations. Reuse is not recommended or supported by the manufacturer.

  • What gauge sizes and lengths are available for the Seirin Jr Acupuncture Needles?

    The Seirin Jr Acupuncture Needles come in a variety of gauge sizes and lengths, identified by FEI numbers such as 3005417950, 3033906329, 3012449047, and others. These variations allow practitioners to select the appropriate size for different patient needs and treatment preferences.

  • How should these needles be stored to maintain sterility?

    Storage should follow the manufacturer’s guidelines to preserve sterility and integrity. Typically, this involves keeping the sealed, sterile packaging intact until use and storing the needles in a clean, dry environment away from direct sunlight or extreme temperatures.

  • Are these needles FDA-cleared, and what does that mean?

    Yes, the Seirin Jr Acupuncture Needles have received FDA 510(k) clearance, which means they are classified as substantially equivalent to a legally marketed device already on the market. This clearance confirms they meet regulatory standards for safety and effectiveness as single-use acupuncture needles.