K980061 is an FDA 510(k) clearance for the EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER. This device is classified as a Cannula, Intrauterine Insemination (Class II - Special Controls, product code MFD).
Submitted by Rocket Medical Plc (Stamford, US). The FDA issued a Cleared decision on March 2, 1998, 54 days after receiving the submission on January 7, 1998.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K980061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1998 |
| Decision Date | March 02, 1998 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MFD - Cannula, Intrauterine Insemination |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5250 |