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510(k) Data Aggregation
K Number
K190264Device Name
Viola
Manufacturer
Date Cleared
2019-08-15
(188 days)
Product Code
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
MEDITIME Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
VIOLA barbed suture comprised of dyed polydoxanone (PDO) is indicated for use in soft tissue approximation where use of absorbable suture is appropriate
Device Description
The Viola barbed suture is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of over 99.9% of polydioxanone, and dyed with 0.05-0.075% of D&C Violet No 2. The Viola suture has 85 Cog shaped barbs distributed along the suture with a barb size of 0.567mm. The device is designed with small bi-directional barbs along the long axis of the suture monofilament to prevent sliding back and forth of the suture in tissue. VIOLA suture does not need surgical knots after tissue approximation. It is available in diameter size USP 0 through 4-0 in various lengths, and affixed to stainless steel S.S 304 needle size from 19G to 26G. The VIOLA suture is sterilized by ethylene oxide gas and packed each set in a poly bag.
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