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510(k) Data Aggregation
K Number
K160761Device Name
DW-1C
Manufacturer
Date Cleared
2016-11-22
(246 days)
Product Code
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
DONGWON MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DW-1 C comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Device Description
DW-1C synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The DW-1C is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The DW-1C Synthetic Absorbable PDO suture approximate tissue, without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues.
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