510(k) Report

FDA product code · General and plastic surgery

Expander, Breast, External

MWZClass I21 CFR 890.56601 decision since 19770 recalls

1 FDA decision since 1977. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of MWZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MWZ

FDA has decided no MWZ device since 2007.

Median 510(k) review, days · MWZ

Too few MWZ 510(k)s in any year since 2007 to give a median.

Recalls per year · MWZ

No recall names MWZ since 2007.

Adverse event reports per year · MWZ

No MAUDE report names MWZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MWZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MWZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in MWZ lately?

  • K770082Salonmay Bustline IncreaserGamma Enterprises, Inc. · 1977

The one MWZ decision →

Related product codes

Other codes under 21 CFR 890.5660.

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