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510(k) Data Aggregation
K Number
K091355Device Name
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
Manufacturer
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
Date Cleared
2009-07-22
(75 days)
Product Code
FDI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
May be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.
Device Description
The ConMed Deuce Polypectomy Snare is a sterile, single patient use, disposable device used in conjunction with an electrosurgical generator for the delivery of electrosurgical current through a flexible endoscope to a stainless steel wire snare at the operative site for endoscopic resection of a polypoid lesion.
The snare consists of a non-detachable handle with a sliding finger ring mechanism for retracting/extending the distal snare loop. An external sheath covers the snare loop cable and is attached to the distal portion of the snare handle. Within the handle, an electrode completes the circuit between the electrosurgical unit and the snare loop.
The polypectomy snares are manufactured in 230cm sheath lengths with a 2.3mm outer diameter in a variety of different loop configurations.
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K Number
K080946Device Name
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX
Manufacturer
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
Date Cleared
2008-05-20
(47 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.
Device Description
The ConMed Axcess Papillotome is a multi-directional wire-guided tapered radiopaque tip catheter capable of accepting a .035" (.889 mm) guidewire. The Axcess Papillotome is a triple lumen device tapered from 7 to 4.5F over the distal 5mm. It has a 5mm tip and distal flexible section running from the proximal to the distal end of the cutting wire that allows multi-directional control of the device distal tip. The working length is 190cm.
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