FDA product code · Obstetrics and gynecology

Aspirator, Ultrasonic

Name: FDA decisions, review times, recalls and adverse event reports for product code MGI
Creator: 510(k) Report

MGIClass IIIPathway set case by case1 decision since 19920 recalls

1 FDA decision since 1992. 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, obstetrics and gynecology panel

Twenty years of MGI 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 · MGI

FDA has decided no MGI device since 2007.

Median 510(k) review, days · MGI

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

Recalls per year · MGI

No recall names MGI since 2007.

Adverse event reports per year · MGI

1in 2014

2007high 3 (2013) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	3
2014	—	1
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — MGI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MGI? 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

Aspirator, Ultrasonic

What has FDA decided in MGI lately?