510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170049Unknown

Innovo

Bio-Medical Research, Ltd., Galway, IE / Direct, Unknown
FDA source (opens on fda.gov)

DEN170049 is the FDA 510(k) clearance record for Innovo, a class II device, cleared for Bio-Medical Research, Ltd. on under FDA product code QAJ (Cutaneous Electrode Stimulator For Urinary Incontinence). FDA's definition for product code QAJ reads: "A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence". FDA records list 37 510(k) clearances for Bio-Medical Research, Ltd., from to . As of , FDA records show no recalls naming DEN170049.

Clearance record

Decision date
Received
(414 days to decision)
Product code
QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Regulation
21 CFR 876.5330
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bio-Medical Research, Ltd. Parkmore Business Park W., Galway, IE
Third party review
No

Clearances, product code QAJ

Trailing 12 months
1 clearance under product code QAJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QAJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260