Cleared Traditional

K963769 - SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES

K963769 is an FDA 510(k) clearance for SEIRIN SPINEX INTRADERMAL ACUPUNCTURE N..., manufactured by Seirin-America, Inc.. The device is a Class 2 General Hospital device with product code MQX cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K963769 · Seirin-America, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
27d
Days
Class 2
Risk

K963769 is an FDA 510(k) clearance for the SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES. Classified as Needle, Acupuncture, Single Use (product code MQX), Class II - Special Controls.

Submitted by Seirin-America, Inc. (Weymouth, US). The FDA issued a Cleared decision on October 16, 1996 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K963769

510(k) Number K963769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1996
Decision Date October 16, 1996
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 K963769.
TAKI ACUPUNCTURE NEEDLES
K964411 · Lhasa Medical, Inc. · Dec 1996
NEEDLE, ACUPUNCTURE
K964051 · S-Tcm Enterprises, Inc. · Nov 1996
ACUPUNCTURE NEEDLES
K961677 · K.S. Choi Corp. · 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
HUA-XIA ACUPUNCTURE NEEDLES
K962916 · Lhasa Medical, Inc. · Aug 1996
K963769 · SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES
Download PDF FDA Summary Seirin-America, Inc.