Precision Press Tack, Intraderm, Seven Star, Alpha and Fine Point Acupuncture Needles
510(k) K061517
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061517 | Date22 Nov 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Precision Press Tack / Intraderm, Seven Star and Acupuncture Needles; Alpha and Fine Point Acupuncture Needles
- 510(k) Number
- FDA Product Code
- MQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5580
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
These devices are acupuncture needles designed to pierce the skin for acupuncture therapy. They are used by qualified practitioners to perform clinical acupuncture procedures.
These needles are supplied as sterile, single-use devices. This product is authorized under FDA 510(k) number K061517.
Other devices from Prime Herbs Corporation
Questions
AI-generated answers, 24 Sep 2026
What are these needles used for?
These devices are designed to pierce the skin for the purpose of performing clinical acupuncture therapy.
Are these needles reusable?
No, these are single-use devices. They must be disposed of after a single application to ensure patient safety and maintain sterility.
How are these needles supplied?
The needles are supplied in a sterile condition, ready for use by qualified practitioners in a clinical setting.
What is the regulatory status of these needles?
These acupuncture needles are authorized under FDA 510(k) number K061517.