Access and Dissector System
- UID
- IMP/MD/2018/000215_e678aaa4792bc654a2cb074a12380f5b_be6d0e33e6d1a096338e34dbca095892
- Device class
- Class B
- Brand name
- Endo Shears™ Auto Suture™ Shears
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The Spacemaker Pro dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space. The Spacemaker Pro blunt tip trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery. The Spacemaker™ Pro structural balloon trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.
Access and Dissector System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000215_e678aaa4792bc654a2cb074a12380f5b_be6d0e33e6d1a096338e34dbca095892. This device is marketed under the brand name Endo Shears™ Auto Suture™ Shears. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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