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JIN ACUPUNCTURE NEEDLES - Si

by Kenshin Trading Corp.

510(k) K980899

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 NumberK980899 Date11 Jun 1998ClearedStatusActive

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  • Withdrawn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
Models / Variants
Si
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.

The Jin Acupuncture Needles are single-use, surgical-grade stainless steel needles used for piercing the skin in the practice of acupuncture. They are available in multiple models, including ST, GL, SI, PT, and ID, each with distinct features such as pressed pipe-type metal handles or intradermal needles with flat handles.

The needles are supplied sterile and are intended for use by qualified practitioners. They are available in various sizes and models, and their packaging includes warnings. The device has been cleared with the FDA 510K authorization, and its regulation number is 880.5580.

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 are Jin Acupuncture Needles used for?

    Jin Acupuncture Needles are used for piercing the skin in the practice of acupuncture by qualified practitioners.

  • Are Jin Acupuncture Needles supplied sterile?

    Yes, Jin Acupuncture Needles are supplied sterile to ensure safety and hygiene during use.

  • What models of Jin Acupuncture Needles are available?

    Jin Acupuncture Needles are available in multiple models, including ST, GL, SI, PT, and ID, each with distinct features.