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510(k) Data Aggregation
K Number
K232355Device Name
Non absorbable Surgical Silk Suture
Manufacturer
Shandong Haidike Medical Product Co., Ltd.
Date Cleared
2024-01-16
(162 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
Shandong Haidike Medical Product Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non absorbable Surgical Silk 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
Non absorbable Surgical silk Suture is a nonabsorbable, braided surgical suture which is supplied sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori of the family Bombycidae. Silk for braided material is processed to remove the natural waxes and gums. Silk suture is dyed black(Logwood extract) and coated with silicone. The quantity of color additive is not to exceed 1.00% by weight of the suture. The 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. Silk suture meets all the requirements of USP for nonabsorbable surgical suture. The suture needle are made from medical stainless steel, the grade of medical stainless steel is SUS 420 J2.
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K Number
K212603Device Name
Non Absorbable Surgical Nylon Suture
Manufacturer
Shandong Haidike Medical Product Co., Ltd.
Date Cleared
2021-12-22
(127 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
Shandong Haidike Medical Product Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.
Device Description
The proposed device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed 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. The proposed device is dyed blue. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%.
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