510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN000002Unknown

Urosurge Percutaneous Sans (Stoller Afferent Nerve Stimulator) Device

Urosurge, Inc., Coralville IA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN000002 is the FDA 510(k) clearance record for UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE, a class II device, cleared for Urosurge, Inc. on under FDA product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence). FDA records list 4 510(k) clearances for Urosurge, Inc., from to . As of , FDA records show no recalls naming DEN000002.

Clearance record

Decision date
Received
(13 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
Urosurge, Inc. 2660 Crosspark Rd., Coralville IA
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