SOFTSEAL HSG CATHETER— 510(k) K040238

Substantially Equivalent

Modern Medical Equipment Mfg., Ltd.

FDA 510(k) clearance K040238 for SOFTSEAL HSG CATHETER, Substantially Equivalent on 2004-06-22. Applicant: Modern Medical Equipment Mfg., Ltd..

Clearance details

Applicant: Modern Medical Equipment Mfg., Ltd.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2004-01-26
Decision date: 2004-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, 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.