FDA product code MWZ: Expander, Breast, External

MWZ is the FDA product code for expander, breast, external. It is a Class I device, regulated under 21 CFR 890.5660 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under MWZ. The average 510(k) review took 61 days (median 61).

Classification

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

Top MWZ applicants

Most recent MWZ clearances

Recalls for MWZ devices

openFDA lists no recalls for product code MWZ.

Frequently asked questions

What is FDA product code MWZ?

MWZ is the FDA product code for expander, breast, external. It is a Class I device, regulated under 21 CFR 890.5660 and reviewed by the General and Plastic Surgery panel.

What device class is MWZ?

Class I, regulation 21 CFR 890.5660. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 61 days from receipt to decision (median 61).

Which companies have the most MWZ clearances?

Gamma Enterprises, Inc. (1).

Next steps

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