K192357 is an FDA 510(k) clearance for the INNOVO. This device is classified as a Cutaneous Electrode Stimulator For Urinary Incontinence (Class II - Special Controls, product code QAJ).
Submitted by Atlantic Therapeutics, Ltd. (Galway, IE). The FDA issued a Cleared decision on January 16, 2020, 140 days after receiving the submission on August 29, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5330. A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence..
| 510(k) Number | K192357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2019 |
| Decision Date | January 16, 2020 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QAJ - Cutaneous Electrode Stimulator For Urinary Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5330 |
| Definition | A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence. |