URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12— 510(k) K061333

Substantially Equivalent

Uroplasty, Inc.

FDA 510(k) clearance K061333 for URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12, Substantially Equivalent on 2006-07-03. Applicant: Uroplasty, Inc..

Clearance details

Applicant: Uroplasty, Inc.
Product code: Code NAM
Advisory panel: Gastroenterology, Urology
Date received: 2006-05-12
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Special
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.