510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192357Substantially Equivalent

Innovo

Atlantic Therapeutics, Ltd., Galway, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192357 is the FDA 510(k) clearance record for INNOVO, a class II device, cleared for Atlantic Therapeutics, 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 one 510(k) clearance for Atlantic Therapeutics, Ltd. As of , FDA records show no recalls naming K192357.

Clearance record

Decision date
Received
(140 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
Atlantic Therapeutics, Ltd. Parkmore Business Park W., Galway, IE
510(k) summary
Summary PDF
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