MARINA MEDICAL SILICONE PESSARY— 510(k) K031463

Name: FDA 510(k) clearance K031463
Creator: U.S. Food and Drug Administration
Published: 2003-11-18

Substantially Equivalent

Marina Medical Instruments, Inc.

FDA 510(k) clearance K031463 for MARINA MEDICAL SILICONE PESSARY, Substantially Equivalent on 2003-11-18. Applicant: Marina Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Marina Medical Instruments, Inc.
Product code: Code HHW
Device class: Class 2
Regulation: 21 CFR 884.3575
Advisory panel: Obstetrics/Gynecology
Date received: 2003-05-08
Decision date: 2003-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, 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.