Bipolar Hand Instruments - India CDSCO Medical Device Registration

Bipolar Hand Instruments is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000009_bccdd52614df504791b8532e57a2651e_5519bbafc3f3f08b850b9dec8dd99441. This device is marketed under the brand name HICURA- Handle. The license holder is Olympus Medical Systems India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Bipolar Hand Instruments

UID: IMP/MD/2018/000009_bccdd52614df504791b8532e57a2651e_5519bbafc3f3f08b850b9dec8dd99441

Brand Name

HICURA- Handle

License Holder

Olympus Medical Systems India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The hand instruments are intended to be used in laparoscopic and endoscopic diagnosis and treatment in the abdomen and thorax. Specific indications: – Thoracical inspection and treatment of organs with minimal-invasive thoracic access – Transabdominal, inspection and treatment of organs with minimal-invasive abdominal access within the retroperitoneal and peritoneal cavities. – Transabdominal, inspection and treatment of organs with single incision abdominal access within the retroperitoneal and peritoneal cavities. – Application of mechanical forces on tissue (HICURA- Handle) and transmitting of high frequency electrical energy for cutting, coagulation and/or carbonization of tissue