FDA product code FXW: Shoes, Operating-Room

FXW is the FDA product code for shoes, operating-room. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FXW. The average 510(k) review took 213 days (median 213).

Classification

Compare with all 510(k) review times · Search every FXW clearance

Top FXW applicants

Most recent FXW clearances

Recalls for FXW devices

openFDA lists no recalls for product code FXW.

Frequently asked questions

What is FDA product code FXW?

FXW is the FDA product code for shoes, operating-room. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General and Plastic Surgery panel.

What device class is FXW?

Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code FXW?

Across 1 cleared submissions the average was 213 days from receipt to decision (median 213).

Which companies have the most FXW clearances?

Dynatech Medical Products (1).

Next steps

• Run an FDA pathway report with predicate devices for product code FXW
• Run a recall and safety report across every FXW manufacturer
• Watch product code FXW for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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