513g Submission

Working with a team of students who designed an attachment for an otoscope to simplify the ease of inspecting a patients ear and extracting earwax. The predicate device, malleus nippers, is a Class I device and 510(k) exempt, thus requiring a 513g submission to obtain advice from the FDA to proceed on the right track for the team. In the 513g submission I included information about risks, safety, and effectiveness.