VACUUM CUP (004SD)— 510(k) K963287

Substantially Equivalent

Swift Delivery Products

FDA 510(k) clearance K963287 for VACUUM CUP (004SD), Substantially Equivalent on 1996-10-28. Applicant: Swift Delivery Products.

Clearance details

Applicant: Swift Delivery Products
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1996-08-21
Decision date: 1996-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, 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.