URGENT PC NEUROMODULATION SYSTEM— 510(k) K052025

Substantially Equivalent

Uroplasty, Inc.

FDA 510(k) clearance K052025 for URGENT PC NEUROMODULATION SYSTEM, Substantially Equivalent on 2005-10-17. Applicant: Uroplasty, Inc..

Clearance details

Applicant: Uroplasty, Inc.
Product code: Code NAM
Advisory panel: Gastroenterology, Urology
Date received: 2005-07-27
Decision date: 2005-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code NAM

product code NAM

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.