510(k) Report

FDA product code · General and plastic surgery

Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)

MXWClass II21 CFR 878.5010510(k) required2 decisions since 20060 recalls

2 FDA decisions since 2006. 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 MXW 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 · MXW

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MXW

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

Recalls per year · MXW

No recall names MXW since 2007.

Adverse event reports per year · MXW

No MAUDE report names MXW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—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 — MXW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MXW? 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

Which MXW devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K060465PremioPeters Surgical · 20071generation

What has FDA decided in MXW lately?

  • K060465PremioPeters Surgical · 2007
  • K052953Nuvance* Facial Rejuvenation SystemETHICON, Inc. · 2006

All 2 MXW decisions →

Related product codes

Other codes under 21 CFR 878.5010.

GAW Suture, Nonabsorbable, Synthetic, Polypropylene