Vygon Spinal Anesthesia Needle W/Introducer 183
FDA 510(k)Class II (US FDA 510(k))
by Vygon Corp.
Identifiers
- 510(k) Number
- K851478 FDA 510(k)
- FDA Product Code
- BSP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5150 FDA 510(k)
- Regulation Number
- 868.5150 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vygon Spinal Anesthesia Needle W/Introducer 183 is a conduction anesthetic needle designed for use in spinal anesthesia and lumbar puncture procedures. It is supplied with a metallic introducer that measures 38 mm in length.
This device is manufactured by Vygon Corp. and is regulated under FDA 510(k) clearance. It is available in 18 and 20 gauge sizes and features either Whitacre or Quincke bevels.
Frequently asked questions
What is the Vygon Spinal Anesthesia Needle W/Introducer 183 used for?
This device is a conduction anesthetic needle specifically designed for performing spinal anesthesia and lumbar puncture procedures.
What components are included with this needle?
The device is supplied with a metallic introducer that measures 38 mm in length to assist in the procedure.
What gauge sizes and bevel types are available?
The needle is available in 18 and 20 gauge sizes and can be selected with either Whitacre or Quincke bevels to suit clinical requirements.
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: Vygon Spinal Anesthesia Needle W/Introducer 183, Spinal anaesthesia and lumbar puncture: Needles - Vygon, PDF K851478 - Vygon Spinal Anesthesia Needle W/Introducer 183, Introducer for spinal needles - Spinal anaesthesia and lumbar ... - Vygon, Device Listing 2015280839 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K851478 | Class II | Active |
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Manufacturer
- Manufacturer
- Vygon Corp.
Sources (1)
- FDA 510(k) K851478 24 fields · synced Sep 25, 2026