SILASTIC BRAND OBSTETRICAL VACUUM CUP— 510(k) K771558

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K771558 for SILASTIC BRAND OBSTETRICAL VACUUM CUP, Substantially Equivalent on 1977-09-20. Applicant: Dow Corning Corp. Healthcare Industries Materials.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1977-08-15
Decision date: 1977-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.