# K970260: Seirin JR Acupuncture Needles

- Pathway: 510(k) (Traditional)
- Applicant: Seirin-America, Inc.
- Decided: Feb 10, 1997 after 18 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Seirin JR 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/K970260
Methodology: https://510kreport.com/methodology