Cleared Traditional

K061517 - PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES

Also marketed or referenced as:
ALPHA AND FINE POINT ACUPUNCTURE NEEDLES

K061517 is an FDA 510(k) clearance for PRECISION PRESS TACK / INTRADERM, manufactured by Prime Herbs Corporation. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K061517 · Prime Herbs Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
174d
Days
Class 2
Risk

K061517 is an FDA 510(k) clearance for the PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Prime Herbs Corporation (Sunnyvale, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 174 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5580 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K061517

510(k) Number K061517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2006
Decision Date November 22, 2006
Days to Decision 174 days
Submission Type Traditional
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
45d slower than avg
Panel avg: 129d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K061517.
HANSO ACUPUNCTURE NEEDLE
K090910 · Hansol Medical Co. · Jun 2009
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
K071524 · Tcm World, Inc. · Apr 2008
BRIO ACUPUNCTURE NEEDLES
K072778 · Helio Medical Supplies, Inc. · Nov 2007
LYRA ACUPUNCTURE NEEDLES
K062448 · Helio Medical Supplies, Inc. · Sep 2006
ASP TITANIUM
K060392 · Sedatelec · Apr 2006
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
K052731 · Daxin LI · Feb 2006
K061517 · PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES
Download PDF FDA Summary Prime Herbs Corporati…