Uresta®— 510(k) K233548

Substantially Equivalent

Resilia, Inc.

FDA 510(k) clearance K233548 for Uresta®, Substantially Equivalent on 2024-04-03. Applicant: Resilia, Inc..

Clearance details

Applicant: Resilia, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2023-11-03
Decision date: 2024-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moncton, CA

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.