510(k) Report

FDA product code · Neurology

Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

SAZClass IIIPMA required1 decision since 20240 recalls

1 FDA decision since 2024. No recall names this code.

As an aid in the management of chronic intractable phantom limb post amputation pain and pain in the residual limb post amputation.

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 SAZ 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 · SAZ

4in 2025

2024: 22025: 42026 (partial year): 3
2007high 4 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SAZ

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

Recalls per year · SAZ

No recall names SAZ since 2007.

Adverse event reports per year · SAZ

3in 2025

2025: 3
2007high 3 (2025) · low 0 (2007)2025

MAUDE reports naming product code SAZ, 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—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
20242—00
20254—03
20263—0—
FIG. 1 — SAZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SAZ? 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