(203 days)
The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in: Diagnostic and operative arthroscope procedures.
Not Found
This document is an FDA 510(k) clearance letter for the AED Arthroscope. It does not contain information about acceptance criteria, study details, or performance data for the device. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.
Therefore, I cannot provide the requested information based on the provided text.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (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.