Chepstow, 12 December 2023 – IQ Endoscopes, a medical device business developing a sustainable single use endoscopy platform has received 510(k) Clearance from the U.S. Food and Drug Administration (FDA) for its first single use gastroscope, the Q Vision G-100. This approval comes just one month after the company achieved UKCA accreditation, marking another hugely critical regulatory milestone for the company. Our aim is to enter the market with a platform of sustainable single use endoscopes to support capacity issues in the NHS and worldwide.
Chris Jenkins, Head of Quality, Regulatory & Compliance at IQ Endoscopes, said: “It is a great pleasure to announce this achievement, especially so soon after our UKCA accreditation. I would like to say a big thank you to the team involved for their hard work on this project. This is a great way to end 2023 and puts us on a strong path towards commercialisation.”
About IQ Endoscopes
IQ Endoscopes is a medical device company based in Chepstow, South Wales. They are a team of clinical, med tech and engineering specialists committed to creating clinically effective, high-performance single-use flexible endoscopes on a global scale.
Using a novel and patented engineering approach, the range of single use endoscopes will deliver much needed change within endoscopy, addressing the huge demand for the service globally. Their mission is to help endoscopists and their service providers improve their way of working, giving them greater flexibility, choice and control so they can increase capacity and ultimately save patients’ lives.
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