K140761 is an FDA 510(k) clearance for the KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA. This device is classified as a Insufflator, Carbon-dioxide, Uterotubal (and Accessories) (Class II - Special Controls, product code HES).
Submitted by Carefusion 2200, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on April 21, 2014, 26 days after receiving the submission on March 26, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1300.
| 510(k) Number | K140761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2014 |
| Decision Date | April 21, 2014 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HES - Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1300 |