Search Results
Found 1 results
510(k) Data Aggregation
K Number
K151072Device Name
Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Manufacturer
Date Cleared
2016-01-22
(276 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
Solo-Dex, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The need to inject and facilitate the continuous and/or internittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures.
In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit, consisting of the peripheral nerve block needle, catheted peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.
Device Description
Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. The Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Ask a Question
Ask a specific question about this device
Page 1 of 1