SWAN VALLEY MEDICAL, INCORPORATED

Swan Valley Medical, Incorporated specializes in designing and manufacturing suprapubic drainage catheters, including systems like the T-SPeC and SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM. These devices are intended for surgical placement to create a urinary drainage pathway in patients who require long-term catheterization, particularly when alternative methods are not feasible.

Swan Valley Medical, Incorporated is based in the United States. Its devices are authorised for use in the U.S. under FDA regulatory pathways, including 510(k) premarket notifications and UDI (Unique Device Identification) listings, reflecting compliance with U.S. medical device regulations.

Swan Valley Medical’s devices fall into Class I and Class II categories under FDA regulations. The classification depends on factors like risk level and intended use. For example, suprapubic drainage catheters are typically Class II due to their surgical placement and potential risks, while simpler variants may qualify as Class I. These classifications determine the regulatory requirements for authorisation.

Swan Valley Medical’s devices are listed in FDA registries, specifically under 510(k) submissions and UDI (Unique Device Identifier) databases. These registries track authorised medical devices in the U.S., ensuring transparency and compliance with FDA requirements for post-market surveillance and reporting.