THE KEEPER— 510(k) K870803

Name: FDA 510(k) clearance K870803
Creator: U.S. Food and Drug Administration
Published: 1987-05-06

Substantially Equivalent

The Keeper Co.

FDA 510(k) clearance K870803 for THE KEEPER, Substantially Equivalent on 1987-05-06. Applicant: The Keeper Co.. Device class: 2.

Clearance details

Applicant: The Keeper Co.
Product code: Code HHE
Device class: Class 2
Regulation: 21 CFR 884.5400
Advisory panel: Obstetrics/Gynecology
Date received: 1987-02-27
Decision date: 1987-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HHE

product code HHE

Injury: 344
Total: 344

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.