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SEIRIN ACUPUNCTURE NEEDLE

SEIRIN CORPORATION · Model J15 (J-Sakura)No.2(0.18)x15mm · UDI-DI 04547248705152

MQX Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The J-15 is perfect for facial, auricular, hand acupuncture, or wherever shallow needling is performed. Available in the thinnest gauges you can find (03, 02, 01, and 1), this 15 mm needle comes with rounded guide tubes for accurate, gentle, painless and stress-free acupuncture. The J-15 also features ProPak™ technology, which allows you to open one or more blister packs quickly and easily. One surgical stainless steel needle per blister package. Features lightweight, color coded, 2.0 x 20 mm easy release comfort grip plastic handle with Light Touch Insertion. Sterile, disposable. Box of 100 needles.

Recalls

Date	Firm	Reason
2007-11-28	Marknew Products	Marketed without 510(k)

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.