Arthroscope

What Is It?

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

What Is FDA Product Code HRX?

Arthroscope is FDA product code HRX, Class 2, 21 CFR 888.1100.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 4 clearances under this code; the FDA took a median of 232 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 126 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Packaging process control (23), Packaging (23) and Process control (18).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.