Angiodynamics Tumescent Infusion Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051142 FDA 510(k)
- FDA Product Code
- FPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Angiodynamics Tumescent Infusion Device is an intravascular administration set classified under the nomenclature for infusion pumps and sets. It is designed specifically for the controlled delivery of dilute lidocaine solutions into subcutaneous tissues, enabling tumescent local anesthesia for surgical procedures.
This device is intended for clinical use by healthcare professionals in a hospital or procedural setting. It is supplied as a single-use, non-sterile administration set and has received FDA 510(k) clearance under the product code FPA. The device is not intended for MRI use and must be handled and stored according to manufacturer instructions to maintain its integrity.
Frequently asked questions
What is the primary purpose of the Angiodynamics Tumescent Infusion Device, and how does it differ from standard infusion sets?
The Angiodynamics Tumescent Infusion Device is specifically designed for the controlled delivery of dilute lidocaine solutions into subcutaneous tissues, enabling tumescent local anesthesia. This distinguishes it from standard infusion sets, as it is tailored for procedures requiring localized anesthesia by infusing fluid slowly beneath the skin to create a swollen, anesthetic state. It is intended for use by healthcare professionals in hospital or procedural settings.
Is the Angiodynamics Tumescent Infusion Device sterile, and how should it be handled to ensure safety?
The Angiodynamics Tumescent Infusion Device is supplied as a single-use, non-sterile administration set. To ensure safety, it must be handled according to the manufacturer’s instructions, which likely include proper cleaning, preparation, and sterile technique for the connected components (e.g., lidocaine solution and needles) before clinical use. The device itself is not sterile, so it should not be reused or reprocessed.
What type of regulatory clearance does this device have, and what does that mean for its use in clinical settings?
The Angiodynamics Tumescent Infusion Device has received FDA 510(k) clearance under product code FPA, which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance allows it to be legally used in clinical settings in the U.S. for its intended purpose—controlled delivery of dilute lidocaine for tumescent anesthesia—following the manufacturer’s instructions.
Can this device be used in MRI environments, and what storage guidelines should be followed?
The device is not intended for MRI use, as explicitly stated in the manufacturer’s instructions. For storage, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures, following the manufacturer’s specific guidelines to maintain its integrity and functionality until use. Always refer to the included instructions for proper handling and storage.
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: ANGIODYNAMICS TUMESCENT INFUSION DEVICE (K051142) — FDA 510 (k ..., ANGIODYNAMICS TUMESCENT INFUSION DEVICE by ANGIODYNAMICS, INC. | FDA ..., PDF K051142 - Angiodynamics Tumescent Infusion Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051142 | Class II | Active |
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Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA 510(k) K051142 24 fields · synced Sep 19, 2026