Atrion Epidural Anesthesia Kit with NeedleVISE Sharps Securing System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K041158 FDA 510(k)
- FDA Product Code
- CAZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5140 FDA 510(k)
- Regulation Number
- 868.5140 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Atrion Epidural Anesthesia Kit is classified as an Anesthesia Conduction Kit, designed for administering anesthetic agents into the epidural space. It includes components for epidural anesthesia procedures, ensuring safe and controlled delivery of medications while mitigating risks associated with needle handling.
The kit is intended for use in sterile anesthesiology settings and includes the NeedleVISE Sharps Securing System for safely securing contaminated needles. Supplied as a single-use device, it adheres to FDA 510(k) clearance under regulation 868.5140, classified as a Class II medical device. Storage and handling must comply with sterile procedure protocols to maintain integrity and safety.
Frequently asked questions
What is the primary purpose of the Atrion Epidural Anesthesia Kit, and how does the NeedleVISE Sharps Securing System enhance safety during use?
The Atrion Epidural Anesthesia Kit is designed for administering anesthetic agents into the epidural space during surgical or procedural anesthesia. The NeedleVISE Sharps Securing System is included to safely secure contaminated needles after use, reducing the risk of accidental needle sticks and improving workplace safety for healthcare providers.
Is the Atrion Epidural Anesthesia Kit intended for single-use or repeated use, and what storage guidelines should be followed?
The kit is explicitly labeled as a single-use device, meaning it should not be reused after one procedure. To maintain sterility and safety, storage must comply with sterile procedure protocols, ensuring the packaging remains intact until immediate use.
How is the regulatory status of this device determined, and which advisory committee was involved in its review?
The kit holds FDA 510(k) clearance under regulation 868.5140, classified as a Class II medical device. It was reviewed by the Anesthesiology (AN) Advisory Committee as part of the traditional clearance process, with a decision of Substantially Equivalent (SESE) made on June 16, 2004.
Are there different sizes or models of the Atrion Epidural Anesthesia Kit, and if so, how would a clinician determine the correct one for a procedure?
The provided data does not specify distinct sizes or models beyond the core kit and NeedleVISE system. Selection would depend on clinical practice guidelines and institutional protocols, as the kit is designed for general epidural anesthesia procedures without size-specific variations mentioned.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Atrion Epidural Anesthesia Kit With Atrion Needlevise Sharps Securing ..., Atrion Epidural Anesthesia Kit With Atrion Needlevise Sharps Securing ..., Atrion Epidural Anesthesia Kit With Atrion Needlevise Sharps Securing ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041158 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrion Medical Products, Inc.
Sources (1)
- FDA 510(k) K041158 24 fields · synced Oct 6, 2026