Laparoscope, General & Plastic Surgery

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 GCJ?

Laparoscope, General & Plastic Surgery is FDA product code GCJ, Class 2, 21 CFR 876.1500.

What Does It Take to Sell It in the United States?

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. Chinese applicants hold 44 clearances under this code; the FDA took a median of 132 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 274 recalls under this product code since 2003. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (65), Packaging process control (50) and Process control (35). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.