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510(k) Data Aggregation
K Number
K230746Device Name
Non absorbable Surgical Polypropylene Suture
Manufacturer
Shandong Haidike Medical Products Co.,Ltd.
Date Cleared
2023-09-14
(181 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
Shandong Haidike Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
Device Description
The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.
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K Number
K231183Device Name
Non absorbable Surgical Polyester Suture
Manufacturer
Shandong Haidike Medical Products Co.,Ltd.
Date Cleared
2023-08-25
(121 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Shandong Haidike Medical Products Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
Device Description
The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6. The subject device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached.
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