K150748 is an FDA 510(k) clearance for the Flexipet Denuding Pipette, Flexipet Manipulation Pipette. This device is classified as a Microtools, Assisted Reproduction (pipettes) (Class II - Special Controls, product code MQH).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 18, 2015, 270 days after receiving the submission on March 23, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6130.
| 510(k) Number | K150748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2015 |
| Decision Date | December 18, 2015 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQH — Microtools, Assisted Reproduction (pipettes) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6130 |