510(k) Report

FDA product code · Neurology

Deep Brain Stimulation For The Treatment Of Dystonia

SGSClass IIIPMA required0 decisions since 20250 recalls

0 FDA decisions since 2025. No recall names this code.

To stimulate deep brain structure to manage dystonia symptoms

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, neurology panel

Twenty years of SGS 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 · SGS

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SGS

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

Recalls per year · SGS

No recall names SGS since 2007.

Adverse event reports per year · SGS

No MAUDE report names SGS 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
20251—00
20260—0—
FIG. 1 — SGS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SGS? 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