← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

QPT — Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
GU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES

Recent clearances

P240011Medtronic Neuromodulation · pma2026-07-13
P200036Boston Scientific Corporation · pma2026-03-03

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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