Asia-Med Acupuncture Needles (Standard, Special, Compact, Apex)
510(k) K011808
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK011808 | Date10 Jul 2001 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 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, 18 Sep 2026
The Asia-Med Acupuncture Needles are single-use, sterile acupuncture needles designed for insertion into the skin at specific acupuncture points. Classified as a Class II medical device, they are intended for use in traditional acupuncture procedures as defined by regulatory authorities.
These needles are supplied in sterile packaging for single-use applications and are regulated under FDA 510(k) clearance and the Medical Devices Directive (MDD). They are available in multiple configurations, including Standard, Special, Compact, and Apex variants, and are intended for use in general hospital settings. No MRI safety information or reusable variants are specified in the data.
Other devices from Asia-Med GmbH and CO KG
Questions
AI-generated answers, 18 Sep 2026
Are these acupuncture needles suitable for reuse, or are they strictly single-use only?
These needles are explicitly designed for single-use only. The product description and regulatory filings confirm they are supplied in sterile packaging, which is standard practice for single-use medical devices to prevent cross-contamination and ensure patient safety.
What configurations or types of needles are available, and how do they differ?
The Asia-Med Acupuncture Needles come in four distinct configurations: Standard, Special, Compact, and Apex. While the exact differences between these types aren’t detailed in the data, the variety suggests variations in needle length, gauge, or design to accommodate different acupuncture techniques or patient needs. The manufacturer’s catalog or technical documentation would provide precise specifications.
How should these needles be stored to maintain their sterility before use?
Since these needles are sterile and single-use, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The sealed packaging ensures sterility until first use, so avoid exposing the packaging to moisture, contamination, or physical damage.
What regulatory pathways have these needles undergone, and where were they originally submitted?
These needles were submitted under FDA 510(k) clearance (K011808) and comply with the Medical Devices Directive (MDD). The submission was filed with the FDA’s Orthopaedic and Rehabilitation Devices Panel (HO) in 2001, with a decision confirming they are substantially equivalent to predicate devices. The product code (MQX) and registration numbers further confirm their regulatory classification.
Are these needles intended for use in any specific clinical setting, or are they broadly applicable?
The needles are intended for use in general hospital settings, as indicated by their regulatory filings and classification. While they are designed for traditional acupuncture procedures, their broad approval suggests they can be used in various clinical environments where acupuncture is practiced, including outpatient clinics, pain management centers, or integrative medicine facilities.