OBSTETRICAL VACUUM CUP— 510(k) K911326

Substantially Equivalent

Gesco Intl., Inc.

FDA 510(k) clearance K911326 for OBSTETRICAL VACUUM CUP, Substantially Equivalent on 1991-08-14. Applicant: Gesco Intl., Inc..

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1991-03-26
Decision date: 1991-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.