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510(k) Data Aggregation
K Number
K240185Device Name
Cypris eXact Suture Placement Device
Manufacturer
Cypris Medical
Date Cleared
2024-05-03
(101 days)
Product Code
GEJ
Regulation Number
878.4800Why did this record match?
Product Code :
GEJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.
Device Description
The Cypris eXact Suture Placement Device is for use in general soft tissue approximation by surgeons, and it is single-use and provided sterile. It is a hand-held device used for the placement of a surgical suture, and the device consists of a handle, needle driver, and tissue capture port. The handle is designed for manual manipulation of the suture placement device, allowing the surgeon to advance the device to the desired deployment site. The needle driver functions to pass the suture when it is advanced and retracted. The tissue capture port consists of a capture chamber, needle, and hook assembly, and holds the tissue to be sutured during either manual palpation or vacuum-assisted palpation of tissue into the tissue capture port. Suture placement is achieved by advancing and retracting the needle driver.
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