Reia pessary— 510(k) K232677

Substantially Equivalent

Reia, LLC

FDA 510(k) clearance K232677 for Reia pessary, Substantially Equivalent on 2024-05-21. Applicant: Reia, LLC.

Clearance details

Applicant: Reia, LLC
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2023-09-01
Decision date: 2024-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lyme, NH, US

Download summary PDF View on FDA.gov ↗

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.