Cleared Traditional

K961677 - ACUPUNCTURE NEEDLES

K961677 is an FDA 510(k) clearance for ACUPUNCTURE NEEDLES, manufactured by K.S. Choi Corp.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K961677 · K.S. Choi Corp. · General Hospital
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Oct 1996
Decision
181d
Days
Class 2
Risk

K961677 is an FDA 510(k) clearance for the ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by K.S. Choi Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 181 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 K.S. Choi Corp. devices

FDA 510(k) Submission Details - K961677

510(k) Number K961677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1996
Decision Date October 28, 1996
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
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 60
Devices cleared under the same product code (MQX) and FDA review panel - the closest regulatory comparables to K961677.
CW ACUPUNCTURE NEEDLES
K964529 · Lhasa Medical, Inc. · Jan 1997
TAKI ACUPUNCTURE NEEDLES
K964411 · Lhasa Medical, Inc. · Dec 1996
NEEDLE, ACUPUNCTURE
K964051 · S-Tcm Enterprises, Inc. · Nov 1996
SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES
K963769 · Seirin-America, Inc. · Oct 1996
HWA-TO ACUPUNCTURE NEEDLES
K963299 · Lhasa Medical, Inc. · Sep 1996
DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)
K963300 · Lhasa Medical, Inc. · Sep 1996