510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K994109Substantially Equivalent

Detrusan 500

Innovamed USA, Inc., Lehigh Acres FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994109 is the FDA 510(k) clearance record for DETRUSAN 500, a class II device, cleared for Innovamed USA, Inc. on under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). FDA records list one 510(k) clearance for Innovamed USA, Inc. As of , FDA records show no recalls naming K994109.

Clearance record

Decision date
Received
(241 days to decision)
Product code
KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation
21 CFR 876.5320
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Innovamed USA, Inc. 1140 Lee Blvd., Suite 101-103, Lehigh Acres FL
510(k) summary
Summary
Third party review
No

Clearances, product code KPI

Trailing 12 months
7 clearances under product code KPI in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20262
May 20262
June 20261
July 20260
August 20260
September 20261
October 20260