K030056 is an FDA 510(k) clearance for the WORRY-REMOVER IRRIGATOR. This device is classified as a Douche Apparatus, Vaginal, Therapeutic (Class I - General Controls, product code HED).
Submitted by Corisen Group, Ltd. (West Chester, US). The FDA issued a Cleared decision on April 22, 2003, 106 days after receiving the submission on January 6, 2003.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5900.
| 510(k) Number | K030056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2003 |
| Decision Date | April 22, 2003 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HED — Douche Apparatus, Vaginal, Therapeutic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.5900 |