CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07

• K Number: K994059
• Device Name: CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
• Manufacturer: HDC CORP.
• Date Cleared: 2000-10-13 ( 319 days)
• Product Code: CAZ
• Regulation Number: 868.5140
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The CLA Kit (Nerve Block Infusion Kit) is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, by use of an insulated hollow needle for electrical stimulation to locate peripheral nerves, and the injection of local anesthetic either directly through the needle, or for up to 72 hours via a catheter inserted through the needle.

Device Description

CLA Kit (Nerve Block Infusion Kit)

AI/ML Overview

This document is a 510(k) clearance letter for the "CLA Kit (Nerve Block Infusion Kit)". It does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the FDA's determination of substantial equivalence to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the provided text.

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).