510(k) Report

FDA product code · General and plastic surgery

Suture, Nonabsorbable

GAOClass II21 CFR 878.4495510(k) required4 decisions since 19800 recalls

4 FDA decisions since 1980. 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 GAO 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 · GAO

FDA has decided no GAO device since 2007.

Median 510(k) review, days · GAO

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

Recalls per year · GAO

No recall names GAO since 2007.

Adverse event reports per year · GAO

26in 2025

2007: 222008: 162009: 172010: 172011: 502012: 282013: 442014: 62015: 62016: 72017: 42018: 62019: 142020: 32021: 82022: 132023: 52024: 122025: 26
2007high 50 (2011) · low 3 (2020)2025

MAUDE reports naming product code GAO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—022
20080—016
20090—017
20100—017
20110—050
20120—028
20130—044
20140—06
20150—06
20160—07
20170—04
20180—06
20190—014
20200—03
20210—08
20220—013
20230—05
20240—012
20250—026
20260—0—
FIG. 1 — GAO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

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Related product codes

Other codes under 21 CFR 878.4495.