PRESS TACK NEEDLE
Device Facts
| Record ID | K042063 |
|---|---|
| Device Name | PRESS TACK NEEDLE |
| Applicant | Asia-Med GmbH & Co. Kg. - Werk Suhl |
| Product Code | MQX · General Hospital |
| Decision Date | Oct 14, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5580 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
Special Controls
*Classification.* Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, (2) Device material biocompatibility, and (3) Device sterility.
