# K963769: Seirin Spinex Intradermal Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Seirin-America, Inc.
- Decided: Oct 16, 1996 after 27 days
- Product code: MQX (Needle, Acupuncture, Single Use)
- Device class: 2
- Regulation: 21 CFR 880.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acupuncture needles: named in the summary without a submission number

## Most influential descendants
- K980471: KHT Guam Needle, Acupuncture Needle (1998), 0 descendants of its own
- K980472: KHT Soft Needle, Acupuncture Needle (1998), 0 descendants of its own

## Indications for use
Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Source page: https://510kreport.com/device/K963769
Methodology: https://510kreport.com/methodology