Cleared Special

K023787 - TAI-CHI AND MASTER ACUPUNCTURE NEEDLES

K023787 is an FDA 510(k) clearance for TAI-CHI AND MASTER ACUPUNCTURE NEEDLES, manufactured by Lhasa Medical, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Special 510(k) pathway after a 93-day FDA review.

K023787 · Lhasa Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
93d
Days
Class 2
Risk

K023787 is an FDA 510(k) clearance for the TAI-CHI AND MASTER ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Lhasa Medical, Inc. (Weymouth, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5580 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023787

510(k) Number K023787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2002
Decision Date February 14, 2003
Days to Decision 93 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

MQX Device Classification - Class 2, Special Controls

Product Code MQX Needle, Acupuncture, Single Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MQX Needle, Acupuncture, Single Use

All 90
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K023787.
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
K031716 · Asia-Med GmbH and CO KG · Jul 2003
VINCO BRAND ACUPUNCTURE NEEDLE
K024207 · Helio Medical Supplies, Inc. · Apr 2003
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
K030190 · Suzhou Sen Sen Medical Supplies , Ltd. · Feb 2003
JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
K023054 · Mandala Health Care, LLC · Nov 2002
MAEDA SILVER ACUPUNCTURE NEEDLE
K021904 · Maeda Toyokichi Shoten · Aug 2002
QIZHOU ACUPUNCTURE NEEDLE
K013926 · Wujiang City Shenli Medical and Health Material CO · Jul 2002
K023787 · TAI-CHI AND MASTER ACUPUNCTURE NEEDLES
Download PDF FDA Summary Lhasa Medical, Inc.