Sealcath, LLC

Sealcath, LLC specializes in single-use medical devices for the lower gastrointestinal tract, including barium enema catheters and enema tips. Their primary products, such as the Cephus Catheter, are designed for procedures like contrast imaging and bowel preparation. These devices are intended for disposable use to maintain hygiene and minimize cross-contamination.

Sealcath, LLC is based in the United States, which means its devices are subject to regulation by the US Food and Drug Administration (FDA). Since the company’s products fall under FDA’s Class I classification—reserved for low-risk devices—they are governed by general controls, including UDI (Unique Device Identifier) registration, rather than stringent pre-market approvals.

Sealcath, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, which are exempt from pre-market approval but still require compliance with FDA requirements, such as proper labeling and manufacturing controls.

Sealcath, LLC’s products, including the Cephus Catheter, are classified as Class I medical devices by the FDA. This classification applies to low-risk items like catheters and enema tips, which are regulated under general controls (e.g., good manufacturing practices, UDI requirements) rather than specialized pre-market reviews. Class I devices are considered safe and effective when manufactured and labeled correctly.