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)
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.

View all Prime Herbs Corporation devices

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
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 21
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K061517.
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · Sedatelec · Aug 1999
DN ACUPUNTURE NEEDLES
K983800 · Sedatelec · Aug 1999
NATURAL BRAND ACUPUNCTURE NEEDLES
K983671 · Tcm Supply Corp. · Mar 1999
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
K981272 · Electro Therapeutic Devices, Inc. · Aug 1998
JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID
K980899 · Kenshin Trading Corp. · Jun 1998
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
K980471 · American Institute of Koryo Hand Therapy · Apr 1998