K180302 is an FDA 510(k) clearance for the Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter. This device is classified as a Catheter, Assisted Reproduction (Class II - Special Controls, product code MQF).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 24, 2018, 264 days after receiving the submission on February 2, 2018.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K180302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2018 |
| Decision Date | October 24, 2018 |
| Days to Decision | 264 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 |