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Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151072

by Solo-Dex, Inc

Identifiers

510(k) Number
K151072 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)

This device is a Needle, Conduction, Anesthetic (With or Without Introducer) designed for continuous peripheral nerve block procedures. It combines a catheter and needle system to facilitate nerve localization via electrical stimulation or ultrasound guidance, enabling sustained regional anesthesia and pain management.

The kit includes a modified Touhy tip needle, memory curve catheter, luer connectors, a 0.2-micron filter, connector tubing, and tubing blocks, all supplied sterile. Intended for use in anesthesiology, it is classified as a Class II device under FDA regulation 868.5150 and received FDA 510K clearance as substantially equivalent. Procedures may include shoulder repair, hip/knee replacement, and general surgical interventions.

Frequently asked questions

What types of surgical procedures is the Solo-Dex Fascile Continuous Peripheral Nerve Block Kit commonly used for?

The Solo-Dex Fascile Continuous Peripheral Nerve Block Kit is primarily designed for procedures requiring sustained regional anesthesia, such as shoulder repairs, hip or knee replacements, and general surgical interventions. Its catheter and needle system enables precise nerve localization, making it suitable for complex or lengthy procedures where prolonged pain management is critical.

Is the Solo-Dex Fascile Continuous Peripheral Nerve Block Kit sterile when supplied, and how should it be stored?

Yes, the kit is supplied sterile as part of its design. Since it is intended for single-use (implied by its sterile packaging and classification as a Class II medical device), it should be stored in a clean, dry environment, protected from contamination, and used immediately upon opening to maintain sterility.

What components are included in the Solo-Dex Fascile Continuous Peripheral Nerve Block Kit, and how does the needle system work?

The kit includes a modified Touhy tip needle, a memory curve catheter, luer connectors, a 0.2-micron filter, connector tubing, and tubing blocks. The needle system is designed for nerve localization via electrical stimulation or ultrasound guidance, allowing anesthesiologists to accurately position the catheter near the target nerve for continuous anesthesia delivery.

How was the Solo-Dex Fascile Continuous Peripheral Nerve Block Kit approved by the FDA, and what does this mean for its use?

The device received FDA clearance through a 510(k) premarket notification process, determined to be substantially equivalent to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness as a Class II conduction needle (with or without introducer) for continuous peripheral nerve block procedures, ensuring it can be legally marketed and used in clinical settings as described.

What specialties or clinical settings would primarily benefit from using this device?

The Solo-Dex Fascile Continuous Peripheral Nerve Block Kit is explicitly designed for use in anesthesiology, particularly for procedures requiring regional anesthesia. Clinicians in orthopedic surgery (e.g., joint replacements), shoulder surgery, or general surgery may find it valuable for postoperative pain management, as it facilitates prolonged nerve blockade with minimal systemic side effects.

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: About Solo-Dex Fascile® Continuous Nerve Block Products (CPNB), Solo-Dex, Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Solo-Dex, Inc
FDA Applicant
Solo-Dex, Inc.

Sources (1)

  • FDA 510(k) K151072 24 fields · synced Sep 20, 2026