K000340 is an FDA 510(k) clearance for the HYSTALOG HSG CATHETER. This device is classified as a Insufflator, Carbon-dioxide, Uterotubal (and Accessories) (Class II - Special Controls, product code HES).
Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on April 19, 2000, 76 days after receiving the submission on February 3, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1300.
| 510(k) Number | K000340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2000 |
| Decision Date | April 19, 2000 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HES - Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1300 |