Coral Medical, Inc.

Coral Medical, Inc. specializes in surgical tools, including an electrosurgical pencil (like the MODEL PBD ESU PENCIL) used for cutting and coagulating tissue during procedures, as well as a disposable suture device (QUIK-STITCH) designed for rapid tissue approximation. These products are intended for use in surgical settings where precision and efficiency are critical.

Coral Medical, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards, including those governing medical device manufacturing and distribution.

Coral Medical’s devices are classified as Class II medical devices by the FDA. This classification applies to products that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. Class II devices typically require a 510(k) clearance before commercial distribution.

Coral Medical’s devices are listed in the FDA’s 510(k) clearance database, which tracks medical devices that have undergone the premarket submission process to demonstrate substantial equivalence to a legally marketed predicate device. This registry confirms that the devices meet FDA requirements for safety and performance before entering the market.