510(k) Report

FDA product code · General and plastic surgery

Marker, Suture Identification

MAWClass I21 CFR 878.4800510(k) required1 decision since 19890 recalls

1 FDA decision since 1989. 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 MAW 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 · MAW

FDA has decided no MAW device since 2007.

Median 510(k) review, days · MAW

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

Recalls per year · MAW

No recall names MAW since 2007.

Adverse event reports per year · MAW

No MAUDE report names MAW 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 — MAW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MAW? 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 MAW lately?

  • K896472Key Vascular BootiesKey Surgical, Inc. · 1989

The one MAW decision →

Related product codes

Other codes under 21 CFR 878.4800.

PYH Surgical Retractor KitPXS Cholecystectomy KitPYF Sterile Puncture TrayGDN Knife, AmputationPIR Mercy Tape 2d And 3d ModelsDWO Needle, Biopsy, CardiovascularHBT Applier, Hemostatic ClipGAD RetractorMCZ Suture Removal KitGAE Snare, SurgicalHCF Instrument, Ligature Passing And Knot TyingGDZ Handle, Scalpel