Air Bubble Based Infuser (ABBI)— 510(k) K143415

Substantially Equivalent

CooperSurgical, Inc.

FDA 510(k) clearance K143415 for Air Bubble Based Infuser (ABBI), Substantially Equivalent on 2015-02-26. Applicant: CooperSurgical, Inc..

Clearance details

Applicant: CooperSurgical, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2014-11-28
Decision date: 2015-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trumbull, CT, US

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Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.