Cook Instinct Plus® Endoscopic Clipping Device
- Registration number
- DE0510473
- Model name
- Instinct Plus™ Endoscopic Clipping Device
- Model identifier
- INSC-P-7-230-S
- Registration date
- March 17, 2025
- Source update date
- April 13, 2026
- Risk class
- Class C
- Product owner
- Wilson-Cook Medical, Inc
- Registrant / registration holder
- COOK SOUTH EAST ASIA PTE LTD
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking, 2.Hemostasis for • Mucosal/submucosal defects less than 3 cm, • Bleeding ulcers, • Arteries less than 2 mm, • Polyps less than 1.5 cm in diameter, • Diverticula in the colon, and • Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively, 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.
- Product owner address
- 4900 Bethania Station Road, Winston-Salem, NC 27105, United States
- Registrant address
- 38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.