Sheath, Stopcock Accessory— 510(k) K213207

Substantially Equivalent

Olympus Winter & Ibe GmbH

FDA 510(k) clearance K213207 for Sheath, Stopcock Accessory, Substantially Equivalent on 2021-12-22. Applicant: Olympus Winter & Ibe GmbH.

Clearance details

Applicant: Olympus Winter & Ibe GmbH
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2021-09-29
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.