WELLINGTON HOSPITAL PATTERN SELF-RETAIN— 510(k) K843388

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K843388 for WELLINGTON HOSPITAL PATTERN SELF-RETAIN, Substantially Equivalent on 1984-10-01. Applicant: Downs Surgical , Ltd..

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code HDF
Advisory panel: Obstetrics/Gynecology
Date received: 1984-08-29
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HDF

product code HDF

Other: 2
Total: 2

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.