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510(k) Data Aggregation
K Number
K032981Device Name
SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
Manufacturer
Date Cleared
2004-04-22
(211 days)
Product Code
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
INVAMED TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.
Device Description
The SPpro™ ESP anesthesia conduction needle is a single use device for injection of local anesthetics into body cavities other than blood vessels. The device will be packaged as sterile single units or incorporated into kits. The device is designed with a tip shield and sheath mechanism integrated with the introducer hub to aid in the prevention of sharps injuries. After activation the shield covers the introducer tip. The device is disposed of according to institutional procedure in a sharps container.
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