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Apex®M

Model 3100000A1 · INCONTROL MEDICAL, LLC · DI 00851508007035

KPI — Stimulator, Electrical, Non-Implantable, For Incontinence · Class II · 21 CFR 876.5320

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01112026-02: 0 reports for this device; peer average 1/device02
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2026-0201
This device (reports/month)Average device in KPI (reports/device/month)

Regulatory clearances

  • K150183 SESE 2015-04-09 (k number procode)

Predicate lineage

K150183 — cites (transitively): K110179 (d1), K131420 (d1), K134020 (d1), K141158 (d1), K050483 (d2), K053434 (d2), K080950 (d2) — cited as predicate by K163288, K182022

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — INCONTROL MEDICAL, LLC

  • Warning Letter 2012-11-09 InControl Medical, LLC
  • Warning Letter 2012-11-09 InControl Medical, LLC
  • VAI 2017-02-14 InControl Medical, LLC · 1 citations
  • VAI 2017-02-14 InControl Medical, LLC · 1 citations
  • VAI 2013-07-17 InControl Medical, LLC · 10 citations
  • VAI 2013-07-17 InControl Medical, LLC · 10 citations
  • OAI 2012-08-21 InControl Medical, LLC · 11 citations
  • OAI 2012-08-21 InControl Medical, LLC · 11 citations