OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190— 510(k) K123365

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K123365 for OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190, Substantially Equivalent on 2013-03-01. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2012-10-31
Decision date: 2013-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.