FDA 510(k) Approval for Reusable 3mm PretzelFlex™
Surgical Innovations (SI), the designer and manufacturer of creative solutions for minimally invasive surgery ('MIS'), announces that it has received 510(k) clearance from the US Food and Drug Administration ('FDA') for its Reusable 3mm PretzelFlex™ device.
This clearance permits the use of the 3mm PretzelFlex™ in the US market for organ and tissue retraction. The device is easily inserted through a 3mm laparoscopic port and when deployed, forms the unique pretzel shape by way of patented segment technology. The 3mm PretzelFlex™ device combines strength and stability within a significantly reduced profile to support organ retraction through a smaller port incision, which makes it a particularly useful tool in minimally invasive paediatric surgery.
The 3mm PretzelFlex™ is a strategic line extension to the recently launched 5mm PretzelFlex™ (FDA approval for which was announced in March 2012) and complements the SI 3mm YelloPort+plus™ Access system. The company looks forward with confidence to the forthcoming US product launch.
Graham Bowland, Chief Executive Officer, commented: "I am delighted we have attained FDA approval for the 3mm PretzelFlex™ device. Such technology allows us to access new areas of MIS and enhances SI's reputation as a leader in innovative organ retraction devices."