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510(k) Data Aggregation
K Number
K201139Device Name
WEGO-PDO Barbed Suture
Manufacturer
Foosin Medical Supplies Inc., Ltd.
Date Cleared
2020-10-20
(175 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
Foosin Medical Supplies Inc., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The sutures with no needle attachments are only available with bi-directional barbs of 7*7 cm, 10*10 cm, 24*24 cm and 30*30 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2. The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots. The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight. The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
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K Number
K193209Device Name
Wego-Stainless Steel
Manufacturer
Foosin Medical Supplies Inc., Ltd.
Date Cleared
2020-02-19
(90 days)
Product Code
GAQ, GAO
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
Foosin Medical Supplies Inc., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WEGO-STAINLESS STEEL is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
Device Description
The proposed device, WEGO-STAINLESS STEEL, is monofilament, non-absorbable surgical suture composed of stainless steel. WEGO-STAINLESS STEEL is undyed and uncoated. The proposed device is composed of suture and needle. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-STAINLESS STEEL complies with the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
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K Number
K170842Device Name
WEGO-PTFE
Manufacturer
Foosin Medical Supplies Inc., Ltd.
Date Cleared
2017-07-31
(132 days)
Product Code
NBY
Regulation Number
878.5035Why did this record match?
Applicant Name (Manufacturer) :
Foosin Medical Supplies Inc., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
Device Description
The proposed device, WEGO-PTFE, is monofilament, synthetic, non-absorbable surgical suture composed of 100% polytetrafluoroethylene without any additives. The molecular formula is (C-F2)n. WEGO-PTFE is undyed and uncoated.
The proposed device is composed of suture and needle.
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes.
WEGO-PTFE complies with the requirements of the European Pharmacopoeia for Sterile Non-Absorbable Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
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