510(k) Report

FDA product code · Obstetrics and gynecology

Source, Abortion Unit, Vacuum

HGFClass II21 CFR 884.5070510(k) required4 decisions since 19890 recalls

4 FDA decisions 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, obstetrics and gynecology panel

Twenty years of HGF 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 · HGF

FDA has decided no HGF device since 2007.

Median 510(k) review, days · HGF

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

Recalls per year · HGF

No recall names HGF since 2007.

Adverse event reports per year · HGF

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

Planning a device in HGF? 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

Related product codes

Other codes under 21 CFR 884.5070.