GELLHORN PESSARY 33410 VARIOUS SIZES— 510(k) K890565

Name: FDA 510(k) clearance K890565
Creator: U.S. Food and Drug Administration
Published: 1989-03-29

Substantially Equivalent

Medi-Source, Inc.

FDA 510(k) clearance K890565 for GELLHORN PESSARY 33410 VARIOUS SIZES, Substantially Equivalent on 1989-03-29. Applicant: Medi-Source, Inc.. Device class: 2.

Clearance details

Applicant: Medi-Source, Inc.
Product code: Code HHW
Device class: Class 2
Regulation: 21 CFR 884.3575
Advisory panel: Obstetrics/Gynecology
Date received: 1989-02-06
Decision date: 1989-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Syosset, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HHW

product code HHW

Malfunction: 485
Total: 485

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.