Cntrl+ Bladder Support Pessary— 510(k) K240798

Substantially Equivalent

Cntrl+, Inc.

FDA 510(k) clearance K240798 for Cntrl+ Bladder Support Pessary, Substantially Equivalent on 2024-12-17. Applicant: Cntrl+, Inc..

Clearance details

Applicant: Cntrl+, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 2024-03-22
Decision date: 2024-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cornwall, 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.