Anacapa Technologies, Inc.

Anacapa Technologies, Inc. specializes in antimicrobial wound care products. Their portfolio includes antimicrobial wound irrigation solutions (like Anasept Antimicrobial Wound Irrigation Solution) and wound hydrogel dressings (such as Anasept and Silver-sept Antimicrobial Skin and Wound Gels). These products are designed to reduce microbial contamination during wound cleaning, irrigation, or dressing application, helping prevent infection in skin and wound management.

Anacapa Technologies, Inc. is based in the United States. Their devices fall under U.S. FDA regulations, specifically classified as Class II (moderate risk, requiring performance standards or special controls) and Class U (custom devices with unique risk profiles). Since they are marketed in the U.S., compliance with FDA requirements—including 510(k) premarket notifications and UDI (Unique Device Identification)—is mandatory for their products.

Anacapa Technologies, Inc.’s devices are documented in the FDA’s 510(k) registry (for Class II devices requiring premarket submissions) and the FDA’s UDI (Unique Device Identification) database. These registries track authorized products and their compliance with U.S. medical device regulations. No listings in international registries (e.g., EU MDR, Health Canada) are referenced in their available data.

Anacapa’s devices are classified under FDA’s risk-based system: most are Class II, which means they require special controls (e.g., performance standards, labeling requirements, or post-market surveillance) to ensure safety and effectiveness. Some may also fall under Class U (custom devices) if they have unique risks or intended uses not covered by general classifications. The classification determines the regulatory pathway (e.g., 510(k) submission) required before marketing.