K180552 is an FDA 510(k) clearance for the Modified Novy Cornual Cannulation Set. This device is classified as a Catheters, Salpingography (Class II - Special Controls, product code MOV).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 12, 2018, 133 days after receiving the submission on March 1, 2018.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K180552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2018 |
| Decision Date | July 12, 2018 |
| Days to Decision | 133 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MOV — Catheters, Salpingography |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |