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510(k) Data Aggregation
K Number
K091061Device Name
IMPLICITGUIDE SURGICAL SUTURE SYSTEM
Manufacturer
IMPLICITCARE, LLC
Date Cleared
2009-11-13
(213 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
IMPLICITCARE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Implicitguide™ Surgical Suture System is indicated for use in soft tissue approximation and elevation of subdermis and underlying muscle.
Device Description
The ImplicitCare Implicitguide™ Surgical Suture System combines USP size 4-0 braided nonabsorbable poly(ethylene terephthalate), or polyester, surgical suture with a set of manual instruments designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and elevation of subdermis/underlying muscle procedure. All components of the Implicitguide™ Surgical Suture System are provided sterile, and are intended for single use only. The manual instruments consist of the following: Tape (marking tape) to aid in marking the skin for needle (Suturod) point of entry locations)- if needed, Lancet to create a point of entry for needle (Suturod) and suture, Clearing device to clear subcutaneous ligamentous attachments around the puncture site, Two (2) stainless steel Suturods™ which, like suture needles, guide the suture through the tissue. Each Suturod™ has an internal light guide which, when connected to the Light Handle, illuminates the distal tip of the Suturod™M, Light Handle which contains an LED light source to connect to Suturod™.
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