Device, Percutaneous Retrieval

How Is MMX Classified?

Device, Percutaneous Retrieval is FDA product code MMX, Class 2, 21 CFR 870.5150.

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 1 clearance under this code; the FDA took 71 days from receipt to decision.

1 was reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2014. None was by a company in China. 1 is Class I, the most serious grade.

The root cause the FDA records most often is Device Design (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.