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510(k) Data Aggregation
K Number
K102219Device Name
SOCORRO SMI TUNNEL RELEASE DEVICE
Manufacturer
Date Cleared
2010-09-24
(49 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SOCORRO MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Socorro SMI Tunnel Release Device is intended for the minimally invasive examination, isolation and recession/incision of ligament, tendons, or fascia as in:
-Plantar Fasciotomy,
-Carpal Tunnel Release,
-Elbow Cubital Tunnel Release and
- -Gastrocnemius Tenotomy.
Device Description
The SMI Tunnel Release Device is comprised of a hand piece with a tissue cutting probe which is used in conjunction with an endoscope camera and fiber optic illumination system. The device is supplied sterile and is for single use only.
The hand piece provides an actuation member for extending, retracting, and angularly rotating surgical blades which are attached to the distal end of the hand piece. Basic features of these probes are a retraction region and visualization that is nearly threehundred and sixty degrees (360°).
The visualization scope connects with the camera head and optic cables which provide the surgeon a clear and complete view of the surgical site on the overhead monitor.
The endoscope is used to illuminate and visualize the anatomy in or around the operative site. It allows the physician to directly visualize the actions of the probe during the procedure and to verify complete excision of the targeted tissue.
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