FEMALE CONTINENCE DEVICE— 510(k) K883721

Substantially Equivalent

Cook Ob/Gyn

FDA 510(k) clearance K883721 for FEMALE CONTINENCE DEVICE, Substantially Equivalent on 1988-10-03. Applicant: Cook Ob/Gyn.

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 1988-08-31
Decision date: 1988-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.