K040189 is an FDA 510(k) clearance for the ENDOMETRIAL SAMPLING SYRINGE. This device is classified as a Curette, Suction, Endometrial (and Accessories) (Class II - Special Controls, product code HHK).
Submitted by Rocket Medical Plc (Stamford, US). The FDA issued a Cleared decision on October 4, 2004, 250 days after receiving the submission on January 28, 2004.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1175.
| 510(k) Number | K040189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2004 |
| Decision Date | October 04, 2004 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHK - Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1175 |