K122194 is an FDA 510(k) clearance for the LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE. This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by Everyway Medical Instruments Co.,Ltd (Shen Keng Hsiang,Taipei Hsien, TW). The FDA issued a Cleared decision on April 4, 2013, 254 days after receiving the submission on July 24, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K122194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2012 |
| Decision Date | April 04, 2013 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPI — Stimulator, Electrical, Non-implantable, For Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5320 |