K994327 is an FDA 510(k) clearance for the EMBRYON TRANSFER CATHETERS/SETS. This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on February 28, 2000, 68 days after receiving the submission on December 22, 1999.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K994327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1999 |
| Decision Date | February 28, 2000 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQF — Catheter, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6110 |