System Including Single-Use Colonoscope Cleared By FDA

The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to the invendoscopy E200 system for use in endoscopy and endoscopic surgery.

According to the device’s manufacturer, the German company invendo medical, the centerpiece of the system is the invendoscope SC200, which is billed as “the first and only sterile, single use colonoscope.”

In a press release, invendo medical chief commercial officer John Cifarelli details the advantages of the invendoscope SC2000 beyond the reduced risk of infection given its single-use design.

“In addition to the clinical benefits associated with reducing potential cross-contamination, the ergonomic design of the invendoscope SC200 offers a ScopeController that contours to the physician’s hand and can be used attached or detached to the endoscope,” Cifarelli explains. “This unique control body coupled with the lightweight of the colonoscope provides a more comfortable and less tiring procedure for the healthcare provider.”

The invendoscope SC2000 has an insertion length of 170 cm and includes a robotically-assisted tip that allows for more comprehensive exploration of the field during procedures.