K143415 is an FDA 510(k) clearance for the Air Bubble Based Infuser (ABBI). This device is classified as a Cannula, Manipulator/injector, Uterine (Class II - Special Controls, product code LKF).
Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on February 26, 2015, 90 days after receiving the submission on November 28, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K143415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2014 |
| Decision Date | February 26, 2015 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LKF — Cannula, Manipulator/injector, Uterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |