← Product Code [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) · K970370 # TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE (K970370) _Tsk Laboratory, Japan · FMI · Apr 10, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K970370 ## Device Facts - **Applicant:** Tsk Laboratory, Japan - **Product Code:** [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI.md) - **Decision Date:** Apr 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin. ## Device Story TSK STERUEKT is a sterile, single-use hypodermic needle; consists of stainless steel beveled cannula bonded to plastic hub; compatible with standard luer lock or luer slip syringe tips. Used by clinicians for fluid injection or withdrawal from body tissues. Device provides physical conduit for fluid transfer; ensures patient safety through sterile, disposable design; prevents cross-contamination. ## Clinical Evidence Bench testing only. Results: Protector removal and needle bond strength met specifications. Biocompatibility testing passed for sensitization, intracutaneous reactivity, hemolysis, systemic toxicity, and cytotoxicity. LAL pyrogen test passed. ## Technological Characteristics Stainless steel cannula; plastic hub; luer lock/luer slip compatible; sizes 14G-31G; sterile, single-use; removable plastic protector. ## Regulatory Identification A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set. ## Predicate Devices - Becton Dickinson & Company, 'B-D PrecisionGlide' needles ## 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} Attachment VII 510 (k) SUMMARY K970370 TSK STERUEKT Premium Disposable Hypodermic Needle APR 10 1997 Manufacturer: Tochigi Seiko KK 2-1-5 Hirayanagi-cho Tochigi-shi, Tochigi Ken 328 Japan Telephone: +81 282 27 8426 Fax: +81 282 27 1943 510 (k) submitted by: Norman Shane Johnson Distribution Manager TSK Laboratory, Japan 2-1-5 Hirayanagi-cho Tochigi-shi, Tochigi Ken 328 Japan Telephone: +81 282 27 8426 Fax: +81 282 27 1943 Date Summary Prepared: January 10, 1997 Device Trade Name: TSK STERUEKT Premium Disposable Hypodermic Needle Common Name: Hypodermic Needle Classification Name: Hypodermic Single Lumen Needle (per 21CFR 880.5570) Predicate Device: Becton Dickinson & Company, 'B-D PrecisionGlide' needles Description of Device: TSK STERUEKT is a sterile Hypodermic Single Lumen Needle, packaged individually for single patient use. It consists of a stainless steel beveled cannula bonded to a plastic hub. Sizes include 14G-31G and various lengths. The needle is intended to fit any luer lock or luer slip syringe tip. Intended Use: To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin. Safety and Efficacy: The following tests were performed to show the safety and efficacy of the device. | TEST | RESULT | | --- | --- | | Protector Removal | Meets Specification | | Needle Bond Strength | Meets Specification | | Sensitization | Pass | | Intracutaneous | Pass | | Hemolysis | Pass | | Systemic Toxicity | Pass | | LAL Pyrogen Test | Pass | | Cytotoxicity | Pass | Substantial Equivalence: The TSK Premium Disposable Hypodermic Needle and the predicate device, the B-D PrecisionGlide Needle, have been shown to be substantially equivalent based on the following: - identical intended use - disposable sterile hypodermic needle, individually packaged. - equivalent materials - stainless steel cannula and plastic hub. - equivalent design - metal cannula with bonded plastic hub; removable plastic protector on needle tip; sufficient physical integrity for the intended use; fits Luer Lock or Luer Slip hypodermic tips. - similar size range - TSK 14G-31G; B-D 16G-30G. - needle tip selection - both brands are available with several bevels. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K970370](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K970370) **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