BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K210978 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 BD Quincke Spinal Needle, BD Whitacre Spinal Needle, and BD Spinal Introducer Needle are conduction needles designed for anesthetic administration. These devices facilitate regional anesthesia by enabling the precise placement of local anesthetics into the spinal canal, with the introducer needle specifically aiding in the insertion of spinal needles.
These needles are supplied in various sizes, with lengths ranging from 90 mm to 178 mm and gauges from 18 G to 27 G. They are intended for single-use in clinical settings, including anesthesiology, and are classified as Class II medical devices under FDA regulations (868.5150). The BD Quincke and Whitacre needles feature distinct design elements, such as key/slot arrangements and proprietary tipping, to optimize performance and usability.
Frequently asked questions
What are the key differences between the BD Quincke and BD Whitacre spinal needles, and how might they influence my choice for a procedure?
The BD Quincke and BD Whitacre spinal needles differ primarily in their design features. The Quincke needle has a sharp, beveled tip with a key/slot arrangement, which is ideal for procedures requiring precise control and minimal tissue trauma. In contrast, the Whitacre needle features a more rounded, pencil-point tip, designed to reduce tissue damage and improve ease of insertion, particularly useful for delicate spinal procedures. The choice depends on the clinical scenario—Quincke for standard spinal anesthesia and Whitacre for procedures where minimizing tissue disruption is critical.
Are these needles reusable, or are they intended for single-use only? How should they be handled after opening?
These needles are explicitly designed for single-use only in clinical settings. After opening the sterile packaging, they must be used immediately and discarded following a single procedure. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.
What sizes and configurations are available for the BD Spinal Introducer Needle, and how do they differ from the Quincke and Whitacre needles?
The BD Spinal Introducer Needle is available in lengths ranging from 90 mm to 178 mm and gauges from 18 G to 27 G, matching the size range of the Quincke and Whitacre needles. Its primary purpose is to facilitate the insertion of spinal needles by creating a pathway, reducing resistance and improving precision. Unlike the Quincke (sharp tip) or Whitacre (pencil-point tip), the introducer needle has a blunt tip to avoid direct spinal contact, minimizing trauma during needle placement.
How should these needles be stored to maintain sterility and usability before use?
These needles are supplied in sterile packaging and should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain unopened until immediately before use to preserve sterility. Once opened, they should be used promptly and discarded after a single procedure, as reuse is not permitted.
What regulatory pathway was followed for these devices, and what does that mean for clinicians using them?
These needles were cleared through the FDA’s 510(k) process, specifically under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means they meet FDA standards for safety and effectiveness as conduction needles for anesthetic administration in spinal procedures. Clinicians can rely on their compliance with FDA regulations, though local institutional protocols and anesthesiology guidelines should still be followed for procedure-specific use.
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: BD® Quincke Spinal Needles | BD, BD® Whitacre spinal needles | BD, BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210978 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K210978 24 fields · synced Sep 18, 2026