K994417 is an FDA 510(k) clearance for the OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING. This device is classified as a Needle, Assisted Reproduction (Class II - Special Controls, product code MQE).
Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on March 1, 2000, 63 days after receiving the submission on December 29, 1999.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6100.
| 510(k) Number | K994417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1999 |
| Decision Date | March 01, 2000 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQE — Needle, Assisted Reproduction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6100 |