The devices include certain anesthesiology, cardiovascular, general and plastic surgical, and neurological devices. “The FDA believes devices identified in . . . this guidance document are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness.” Until a final rule on the issue is published, the FDA has announced that it does not plan to enforce compliance with 510(k) requirements for devices in the listed categories and does not expect manufacturers to submit 510(k) submissions for these devices.