K142545

Substantially Equivalent

SonoFlow Sonohysterography and Sonohysterosalpingography Device

Applicant: Crossbay Medical, Inc.
Product code: LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2014-09-10
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

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.