WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL— 510(k) K853640

Name: FDA 510(k) clearance K853640
Creator: U.S. Food and Drug Administration
Published: 1985-10-29

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K853640 for WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL, Substantially Equivalent on 1985-10-29. Applicant: Downs Surgical , Ltd.. Device class: 1.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code HDF
Device class: Class 1
Regulation: 21 CFR 884.4520
Advisory panel: Obstetrics/Gynecology
Date received: 1985-08-20
Decision date: 1985-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheffield S9 4wj, GB

Download summary PDF View on FDA.gov ↗

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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.