EZ HSG CATHETER.FOAMSEAL CATHETER— 510(k) K083594

Substantially Equivalent

Obg Products

FDA 510(k) clearance K083594 for EZ HSG CATHETER.FOAMSEAL CATHETER, Substantially Equivalent on 2009-07-21. Applicant: Obg Products.

Clearance details

Applicant: Obg Products
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2008-12-05
Decision date: 2009-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, VA, 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.