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 GEI?
Electrosurgical, Cutting & Coagulation & Accessories is FDA product code GEI, Class 2, 21 CFR 878.4400.
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 50 clearances under this code; the FDA took a median of 214 days from receipt to decision on them.
One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 3 were reviewed by an accredited third party.
What Has Gone Wrong With It?
The FDA has recorded 644 recalls under this product code since 2002. None was by a company in China. 26 are Class I, the most serious grade.
The root causes the FDA records most often are Process control (89), Device Design (82) and Nonconforming Material/Component (57). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.