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510(k) Data Aggregation
K Number
K003102Device Name
PARE ENDOSCOPIC SUTURING SYSTEM
Manufacturer
Date Cleared
2001-02-27
(146 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
PARE SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.
Device Description
The PARÉ Endoscopic Suturing System consists of three concentric tubes and a wire that can fit down the operating channel of a flexible endoscope. Each of the concentric tubes controls a function that is required to do soft tissue suturing at the distal end of the endoscope. These functions include:
- A needle, which is used to puncture through the soft tissue 1.
- 2. A loop, which is used to capture the free end of the suture.
- 3. A holder for the suture that is formed into a pre-tied knot.
- A knot pusher, which also performs the function of cutting the suture once the knot is positioned and formed.
The device will be loaded only with sutures that have received FDA approval for human use.
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