K032015 is an FDA 510(k) clearance for the EMBRYON ULTRASOUND NEEDLE GUIDE. This device is classified as a Needle, Assisted Reproduction (Class II - Special Controls, product code MQE).
Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on August 8, 2003, 39 days after receiving the submission on June 30, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.6100.
| 510(k) Number | K032015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2003 |
| Decision Date | August 08, 2003 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQE - Needle, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6100 |