Endoscope - India CDSCO Medical Device Registration
Endoscope is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000626_b468cc0639998cbc02e3f086feff6d80_7ae50b7a2e7e7d8f4a4f91f3aaa36b4b. This device is marketed under the brand name da Vinci - Si/X/Xi. The license holder is Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
da Vinci - Si/X/Xi
Device Class
Approving Authority
CDSCO
Product Information
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urological surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology robotic surgical procedures restricted to benign and malignant tumors classified as Tl and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (da Vinci - Si/X/Xi). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. The Intuitive Surgical 8.5 mm Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical da Vinci Si Instrument Control System during laparoscopic and thoracoscopic surgical procedures.
Endoscope
KARL STORZ ENDOSCOPY INDIA PRIVATE LIMITED
Endoscope
Brand: SureForm - 45/45 Curved-Tip/60
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Endoscope
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Accessory
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Cannula
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Hasson Cone
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Drapes
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Cannula
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Cannula
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Hasson Cone
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Clip Applier
Brand: SureForm - 45/45 Curved-Tip/60
Suction Irrigator Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Endoscope
Brand: SureForm - 45/45 Curved-Tip/60
Accessory
Brand: 8 mm Endoscope Washer/ Disinfector Connector Set
Accessory
Brand: SureForm - 45/45 Curved-Tip/60
Retractor
Brand: SureForm - 45/45 Curved-Tip/60
Needle Driver Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Obturator(8 mm Bladeless Obturator/ 8mm Bladeless Obturator, Long )
Brand: SureForm - 45/45 Curved-Tip/60
Stapler Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Scissors
Brand: SureForm - 45/45 Curved-Tip/60