Identifiers
- 510(k) Number
- K041843 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)
A Pencil Point Needle is a needle used for conduction anesthesia, specifically designed for anesthetic procedures with or without an introducer. It is classified as a Class II medical device under regulation number 868.5150 and has been determined to be substantially equivalent to a predicate device.
The device is manufactured by Epimed International, Inc. and was cleared via the traditional 510(k) pathway under K041843. It is supplied non-sterile and intended for single-use in anesthesiology settings, with no claims regarding sterility, reusability, MRI safety, or specific sizes provided in the data.
Frequently asked questions
What is the Pencil Point Needle used for?
The Pencil Point Needle is used for conduction anesthesia procedures, either with or without an introducer, as indicated in the device description. It is designed specifically for anesthetic applications in clinical settings where nerve block or regional anesthesia is required.
How is the Pencil Point Needle supplied and is it sterile?
The device is supplied non-sterile, as explicitly stated in the specifications. It is intended for single-use only, with no claims made regarding sterility, reusability, or reprocessing. Users must follow appropriate sterilization protocols before use if required by their institution.
What regulatory pathway was used to clear the Pencil Point Needle?
The Pencil Point Needle was cleared via the traditional 510(k) pathway under submission number K041843, as indicated in the AUTHORIZATIONS and clearance_type fields. It was determined to be substantially equivalent to a predicate device, which is the basis for its FDA 510(k) clearance.
Is the Pencil Point Needle reusable or intended for single use?
The device is intended for single-use only, as clearly stated in the DESCRIPTION section. There are no indications or claims of reusability, and it should not be reprocessed or used on multiple patients due to infection control risks and lack of validation for reuse.
What class of medical device is the Pencil Point Needle?
The Pencil Point Needle is classified as a Class II medical device, as specified in the openfda field under device_class=2 and confirmed by regulation number 868.5150. This classification reflects its risk level and the regulatory controls required for its market distribution.
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: Home - Epimed, PENCIL POINT NEEDLE (K041843) — FDA 510 (k) | Innolitics, PENCIL POINT NEEDLE 510 (k) K041843 - FDA.report, PDF IIGJGZ4? 004 4 ( 3 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041843 | Class II | Active |
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Manufacturer
- Manufacturer
- Epimed International, Inc.
Sources (1)
- FDA 510(k) K041843 24 fields · synced Sep 19, 2026