Intrauterine Access Balloon Catheter, Selective Salpingography Catheter— 510(k) K181770

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K181770 for Intrauterine Access Balloon Catheter, Selective Salpingography Catheter, Substantially Equivalent on 2019-03-29. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2018-07-03
Decision date: 2019-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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.