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658a955f8e10c1b5cdfcfa3c462bc01d

ORISE™ ProKnife Electrosurgical Knife

BOSTON SCIENTIFIC LIMITED·II·Ecuador ARCSA·Registered October 06, 2023
Device classification
Risk class
II
Product type
Invasive
Brand name
ORISE™ProKnife
Commercial name
UNITS FOR ELECTROSURGERY
Registration information
Analysis ID
658a955f8e10c1b5cdfcfa3c462bc01d
Registration date
October 06, 2023
Expiration date
October 06, 2028
Manufacturer
Name
BOSTON SCIENTIFIC LIMITED
Country
IRELAND
Address
BUSINESS AND TECHNOLOGY MODEL FARM ROAD PARK, CORK, IRELAND
Product owner
Name
BOSTON SCIENTIFIC CORPORATION
Country
UNITED STATES
Authorized representative
Name
REGULATEC CIA. LTDA.
Address
THE SN TELEGRAPH AND LATEST NEWS
Phone
2520070
Product use

THE ORISE PROKNIFE HAS BEEN DESIGNED FOR USE WITH ENDOSCOPES AND ELECTROSURGICAL UNITS TO CUT TISSUE WITHIN THE GASTROINTESTINAL TRACT USING HIGH-FREQUENCY CURRENT. THE ELECTROSURGICAL SCALPEL ALSO HAS THE ABILITY TO DELIVER SALINE, SUBMUCOSAL LIFTING AGENT INTO THE SUBMUCOSAL TISSUE LAYERS WITH DIRECT VIEWING THROUGH AN ENDOSCOPE.

About this record

Access comprehensive regulatory information for ORISE™ ProKnife Electrosurgical Knife in the Ecuador medical device market through Pure Global AI's free database. This II medical device is registered under ARCSA ID 658a955f8e10c1b5cdfcfa3c462bc01d and manufactured by BOSTON SCIENTIFIC LIMITED. The device was registered on October 06, 2023.

This page provides complete registration details including product type (Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.