A4722 OLYMPUS OPTICAL OBTURATOR— 510(k) K950055

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K950055 for A4722 OLYMPUS OPTICAL OBTURATOR, Substantially Equivalent on 1995-02-21. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1995-01-06
Decision date: 1995-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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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.