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510(k) Data Aggregation
K Number
K983647Device Name
ECHO-COAT ULTRASOUND NEEDLES
Manufacturer
STS BIOPOLYMERS
Date Cleared
1999-01-20
(96 days)
Product Code
MJG
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
STS BIOPOLYMERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECHO-COAT™ Ultrasound Needle is indicated for use where improved visibility on ultrasound images is required compared to an uncoated needle. The coated needle also assumes the specific indications for use of the currently marketed uncoated needle, for example biopsy, amniocentesis, vascular access, aspiration, and drainage needles.
Device Description
STS Biopolymers, Inc. will purchase in bulk currently marketed needles designated by application (biopsy, aspiration, amniocentesis, etc.), needle type (spinal, Chiba, Franseen, other), needle gauge (11 to 30), and length (3 to 20 cm), and then apply a polymer coating. The coating, called ECHO-COAT™, is visible in ultrasound images, assisting with positioning. The coated needles will be repackaged as single-use devices, sterilized with EtO, and distributed commercially under the STS Biopolymers, Inc. name.
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