Sphincterotome - India CDSCO Medical Device Registration

Sphincterotome is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000084_93ac37c9a3583d26510672366cc66a10_2da3895f1fff15081571f6513af193ed. This device is marketed under the brand name NeedleCut 3V. The license holder is Olympus Medical System India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Sphincterotome

UID: IMP/MD/2018/000084_93ac37c9a3583d26510672366cc66a10_2da3895f1fff15081571f6513af193ed

Brand Name

NeedleCut 3V

License Holder

Olympus Medical System India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

Single Use 3-Lumen Sphincterotome V - These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Single Use Sphincterotome V (NeedleCut 3V) - These instruments (NeedleCut 3V) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts