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

Name: FDA 510(k) clearance K061333
Creator: U.S. Food and Drug Administration
Published: 2006-07-03

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.. Device class: 2.

Clearance details

Applicant: Uroplasty, Inc.
Product code: Code NAM
Device class: Class 2
Regulation: 21 CFR 876.5310
Advisory panel: Gastroenterology, Urology
Date received: 2006-05-12
Decision date: 2006-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K052175 — I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-40002005-10-17
K051905 — UROPLASTY RIGID ENDOSCOPIC NEEDLE2005-08-29

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.