510(k) Report

FDA product code · General and plastic surgery

Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

MGQClass U510(k) required145 decisions since 19915 recalls

145 FDA decisions since 1991. 5 recalls name this code, 0 of them Class I. The most-cited predicate is K041342, named by 17 later devices.

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 MGQ 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 · MGQ

1in 2017

2009: 12017: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MGQ

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

Recalls per year · MGQ

4in 2014

2014: 4
2007high 4 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGQ

5in 2025

2007: 12009: 22010: 32011: 52012: 12013: 42014: 102015: 32016: 42017: 62018: 22019: 22020: 62021: 12023: 62024: 112025: 5
2007high 11 (2024) · low 0 (2008)2025

MAUDE reports naming product code MGQ, 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—01
20080—00
20091—02
20100—03
20110—05
20120—01
20130—04
20140—410
20150—03
20160—04
20171—06
20180—02
20190—02
20200—06
20210—01
20220—00
20230—06
20240—011
20250—05
20260—0—
FIG. 1 — MGQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MGQ? 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