Single Use Guide Sheath Kit-401, K-402— 510(k) K212667

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K212667 for Single Use Guide Sheath Kit-401, K-402, Substantially Equivalent on 2021-09-22. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2021-08-23
Decision date: 2021-09-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

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.