FDA Grants De Novo to Aurie's Reusable Intermittent Urinary Catheter System

The US Food and Drug Administration has granted a De Novo request for the Aurie Reusable No-Touch Intermittent Catheter System, a urinary catheter designed to be cleaned and disinfected between uses, the Syracuse, New York, company said in a May 11 release distributed by PR Newswire.

The FDA's De Novo order, dated April 30, 2026, and addressed to CathBuddy, Inc., the company behind the Aurie brand, classifies the system into Class II under a new generic device type, the reusable intermittent urinary catheter system, with product code SHV. The agency received the request on June 6, 2025, the order says.

What the order covers

The order lists the system as a prescription device "indicated for the drainage of urine from the bladder for adult males requiring intermittent catheterization." It adds: "Prior to use, the Aurie Catheter must be cleaned, high-level disinfected, and lubricated with the Aurie Personal Washer-Disinfector. It is for single patient reuse."

The FDA identified infection from device malfunction or use error, adverse tissue reaction, urinary retention, pain or discomfort, and electrical hazards as the risks of the device type. The special controls it set for future devices of this type include reprocessing and microbicidal validation, human factors testing, use-life testing, and a design that limits the number of catheter uses and includes "a mechanism for tracking and preventing catheter use beyond the indicated use life."

The order says the device type is not exempt from premarket notification, so other companies that want to market a similar system must first submit a 510(k).

The system and the launch plan

Aurie said the system includes a 100-use no-touch intermittent catheter, a portable washer-disinfector and pre-packaged supply pods. The company called it the first reusable intermittent urinary catheter system in an industry that has relied on single-use catheters for decades, and said microbiology and human factors testing showed "reasonable assurance of safety and effectiveness" for its intended use.

As reported by Urology Times, the system previously received designation under the FDA's Safer Technologies Program, which is intended for devices that may significantly improve safety relative to available options.

The company said the system is slated to launch in Veterans Health Administration spinal cord injury hospitals later this year. It did not give pricing.

Aurie also announced that Manu Varma, a former president of North America at Coloplast, has joined its board as an independent director. "The De Novo clearance is a major milestone," Varma said in the release. Christopher Elliott, a clinical associate professor of urology at Stanford University, joined the scientific advisory board, and Sergey Grigoryants was promoted from vice president of engineering to chief technology officer. The company said he will oversee a roadmap that includes catheters with sensors to detect infection.