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510(k) Data Aggregation
K Number
K013889Device Name
ENDOSCOPIC MULTI-FIRE CLIP APPLIER
Manufacturer
INSCOPE, LLC.
Date Cleared
2002-02-07
(76 days)
Product Code
PKL
Regulation Number
876.4400Why did this record match?
Applicant Name (Manufacturer) :
INSCOPE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endoscopic Multi-fire Clip Applier was designed to be used with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis of mucosal and submucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. The device is not intended for repair of gastrointestinal tract lumenal perforations.
Device Description
The InScope Endoscopic Multi-Fire Clip Applier is designed for gastrointestinal endoscopic clipping for marking and hemostasis. It consists of a control handle, an insertion tube, jaws at the distal end for gripping the tissue, and up to 5 clips that can be attached to the tissue individually with each actuation of the device handle. The device is provided sterile and is for one time use only.
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K Number
K992477Device Name
ROTOSNARE
Manufacturer
INSCOPE, LLC.
Date Cleared
1999-08-24
(29 days)
Product Code
FDI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
INSCOPE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InScope, LLC rotatable snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope .
Device Description
The InScope, LLC rotatable snare consists of an actuation handle, rotation handle and snare loop. The loop is attached to the actuation handle by means of a cable. A monopolar electrical connector is provided on the handle and is electrically connected to the snare loop. The rotation handle is positioned on the snare shaft and provides rotation control of the snare loop to aid in orienting the loop with respect to the polyp. Figure 1, Typical Rotatable Snare, shows several views of the rotatable snare.
The InScope, LLC rotatable snares may be used with most monopolar electrosurgical generators. The rotatable snare has a universal connector which is compatible with both Microvasive and Olympus active cord connectors.
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