Code of Federal Regulations Title 21. Food and Drugs § 21.888.1100 Arthroscope

(1) Class II (performance standards).

(2) Class I for the following manual arthroscopic instruments:  cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.