K192164

Substantially Equivalent

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

Applicant: Olympus Medical Systems Corp.
Product code: EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2019-08-09
Decision date: 2020-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.