(56 days)
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation. Previously 2 sizes Mini and Maxi were available, we have now added Super Maxi (Extra Maxi).
This document is a 510(k) summary for the Degania Silicone Identi Loops, specifically addressing the addition of a "Super Maxi" size. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission for a new size of an existing device, emphasizing its substantial equivalence to previous versions, rather than new performance testing.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).