510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132561Substantially Equivalent

Nuro Neuromodulation System

Advanced Uro-Solutions, Inc., Swanee GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132561 is the FDA 510(k) clearance record for NURO NEUROMODULATION SYSTEM, a class II device, cleared for Advanced Uro-Solutions, Inc. on under FDA product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence). FDA records list one 510(k) clearance for Advanced Uro-Solutions, Inc. As of , FDA records show no recalls naming K132561.

Clearance record

Decision date
Received
(82 days to decision)
Product code
NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Regulation
21 CFR 876.5310
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Advanced Uro-Solutions, Inc. 717 Lakeglen Dr., Swanee GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NAM

Trailing 12 months

FDA records hold no clearances under product code NAM in the trailing twelve months.

FDA records show no clearances under product code NAM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260