K040625 is an FDA 510(k) clearance for the ATAD ARD CATHETER, a Dilator, Cervical, Hygroscopic-laminaria (Class II — Special Controls, product code HDY), submitted by Atad Developments , Ltd. (Haifa, IL). The FDA issued a Cleared decision on January 18, 2005, 315 days after receiving the submission on March 9, 2004. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4260.
| 510(k) Number | K040625 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 2004 |
| Decision Date | January 18, 2005 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDY — Dilator, Cervical, Hygroscopic-laminaria |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4260 |