Cleared Traditional

K111392 - WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)

K111392 is an FDA 510(k) clearance for WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPU..., manufactured by Woojeon Company. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K111392 · Woojeon Company · General Hospital
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Nov 2011
Decision
170d
Days
Class 2
Risk

K111392 is an FDA 510(k) clearance for the WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE). Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Woojeon Company (Pittsburgh, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 170 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 Woojeon Company devices

FDA 510(k) Submission Details - K111392

510(k) Number K111392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2011
Decision Date November 04, 2011
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
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.