← Product Code [MQX](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX) · K970254 # SEIRIN PYONEX ACUPUNCTURE NEEDLES (K970254) _Seirin-America, Inc. · MQX · Feb 10, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K970254 ## Device Facts - **Applicant:** Seirin-America, Inc. - **Product Code:** [MQX](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX.md) - **Decision Date:** Feb 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5580 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use Pyonex 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. ## Device Story Sterile, single-use acupuncture needle; intended for skin piercing during acupuncture practice. Operated by qualified practitioners in clinical settings. Device provides therapeutic acupuncture treatment; replaces older non-sterile, reusable needles to improve safety. No reported accidents or failures since 1983. ## Clinical Evidence No clinical data; safety established via historical usage data since 1978 in Japan and 1983 in the USA with no reported accidents or device failures. ## Technological Characteristics Sterile, single-use acupuncture needle. Materials and specifications consistent with standard acupuncture needles. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970254 FEB 10 1997 SEIRIN-America, Inc. 230 Libbey Parkway Weymouth, MA 02189 February 4, 1997 - Revised fax: 617-335-5779 phone: (617) 340-1827 # PRE-MARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.93) Intended Use. Pyonex 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. Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years. Since this time, we are not aware of any serious or life threatening accidents involving acupuncture needles. Acupuncture needles which were sold through commercial interstate distribution prior to May 28, 1976 were non-sterile, reusable acupuncture needles. Acupuncture needles which are currently being marketed through interstate distribution (ie, 1996) offer greater safety since they are sterile, single use only acupuncture needles. The subject of this 510(k) application - the Seirin PYONEX Acupuncture Needle - is a sterile, single use only acupuncture needle. The Seirin PYONEX Acupuncture Needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture. The Seirin PYONEX brand acupuncture needle was first manufactured in Japan in 1978 and has been imported and sold through interstate commerce in the USA since 1983 under the FDA labeling restrictions of: "Caution: Investigational device limited by U.S. law to investigational use". Since 1983, no accidents or device failure claims have been reported as a result of using the Seirin PYONEX brand acupuncture needle. In conclusion, based on the information provided with this 510(k) application, the Seirin PYONEX Acupuncture Needle meets the criteria for 510(k) acceptance. The Seirin PYONEX needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Seirin PYONEX needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce. Thomas A. Riihimäki, President 2/4/97 Date page 7 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K970254](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MQX/K970254) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com