Dr J Spinal and Epidural Needles
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183316 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)
Dr J Spinal and Epidural Needles are anesthetic conduction needles used for spinal and epidural procedures. They are compatible with ISO80369-6 connector standards for neuroanesthesia and are available in K-3 point and pencil point shapes, with options for two-step designs combining both. Multiple sizes, lengths, and colors including PINK, CREAM, YELLOW, GREEN, BLACK, BLUE, PURPLE, ORANGE, BROWN, and GRAY are offered.
Supplied by Dr. Japan Co., Ltd., these needles are classified as Class II medical devices under FDA 510(k) clearance (K183316) with product code BSP and regulation number 868.5150. They are intended for use in anesthesiology and are provided as single-use devices, with sterility and handling dependent on manufacturer specifications not detailed in the provided data.
Frequently asked questions
What are Dr J Spinal and Epidural Needles used for?
Dr J Spinal and Epidural Needles are anesthetic conduction needles used for spinal and epidural procedures, as stated in the device description. They are intended for use in anesthesiology to deliver anesthetic agents into the spinal or epidural space.
How are Dr J Spinal and Epidural Needles supplied and are they single-use?
These needles are supplied by Dr. Japan Co., Ltd. and are provided as single-use devices, meaning they are intended for one procedure only and should not be reused. Sterility and handling depend on the manufacturer's specifications, which are not detailed in the provided data.
What sizes, lengths, and colors are available for Dr J Spinal and Epidural Needles?
The needles are available in multiple sizes, lengths, and colors including PINK, CREAM, YELLOW, GREEN, BLACK, BLUE, PURPLE, ORANGE, BROWN, and GRAY. They also come in K-3 point and pencil point shapes, with options for two-step designs combining both tip types.
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: Spinal needle | Product information | Dr.Japan Co., Ltd., Dr.Japan Co., Ltd. | Manufacture of special medical needles, OEM / ODM ..., Dr J Spinal and Epidural Needles (K183316) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183316 | Class II | Active |
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Manufacturer
- Manufacturer
- Dr.japan Co., Ltd.
- FDA Applicant
- Dr. Japan Co., Ltd.
Sources (1)
- FDA 510(k) K183316 24 fields · synced Sep 21, 2026