MODIFIED DISPOSABLE FETAL VACUUM— 510(k) K915763

Substantially Equivalent

Columbia Medical & Surgical, Inc.

FDA 510(k) clearance K915763 for MODIFIED DISPOSABLE FETAL VACUUM, Substantially Equivalent on 1992-03-18. Applicant: Columbia Medical & Surgical, Inc..

Clearance details

Applicant: Columbia Medical & Surgical, Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1991-12-24
Decision date: 1992-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bend, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HDB

product code HDB

Death: 7
Total: 7

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.