← Product Code [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI) · K960933 # BIO-PLEXUS NEEDLE DISPOSAL CONTAINER (K960933) _Bio-Plexus, Inc. · FMI · Aug 28, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K960933 ## Device Facts - **Applicant:** Bio-Plexus, Inc. - **Product Code:** [FMI](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI.md) - **Decision Date:** Aug 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use The BIO-PLEXUS™ Needle Disposal Container is to receive and accumulate contaminated blood collection needles and accessories in a puncture resistant container until final disposal can occur. The BIO-PLEXUS™ Needle Disposal Container is to be used by healthcare workers in healthcare facilities and in the home healthcare setting for the disposal of contaminated PUNCTUR-GUARD® needles and accessories. ## Device Story Single-use, one-quart, puncture-resistant sharps container; bucket-like base with affixed cover; three openings and two hinged lids; used by healthcare workers in clinical and home settings to receive and accumulate contaminated needles and accessories until final disposal; provides safe containment of sharps to prevent injury. ## Clinical Evidence bench testing only ## Technological Characteristics Polypropylene plastic injection molded bucket and cover; puncture-resistant; one-quart capacity; three openings with two hinged lids. ## 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 - Vacutainer® Needle Disposal Container 367201 ## 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} AUG 28 1996 510 (k) SUMMARY K960933 Bio-Plexus, Inc. 384 Merrow Road Tolland, CT 06084 CONTACT: Carl R. Sahi (President) Prepared: March 6, 1996 Revised: July 9, 1996 | Proprietary Name: | BIO-PLEXUS™ Needle Disposal Container | | --- | --- | | Generic Name: | Sharps Container | | Classification Name: | Accessory to Blood Collection Needles, Winged Sets and Catheters of Appropriate Size | | Class: | II | | Panel Code: | 80 | | Product Code: | FMI | | Reason for submission: | new device | | Bio-Plexus Inc. Registration Number: | 1224632 | The BIO-PLEXUS™ Needle Disposal Container is a single use, one quart, puncture resistant container comprised of a bucket like base and an affixed cover. The bucket and the cover are plastic injection molded from polypropylene. The cover has three openings and two hinged lids. The BIO-PLEXUS™ Needle Disposal Container performs the same function as other legally marketed sharps containers, for example, the Vacutainer® Needle Disposal Container 367201. Specifically, this is to receive and accumulate contaminated blood collection needles and accessories in a puncture resistant container until final disposal can occur. The BIO-PLEXUS™ Needle Disposal Container is to be used by healthcare workers in healthcare facilities and in the home healthcare setting for the disposal of contaminated PUNCTUR-GUARD® needles and accessories. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K960933](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMI/K960933) **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. 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