VAGINAL CONTINENCE DEVICE— 510(k) K930618

Substantially Equivalent

Johnson & Johnson Medical, Inc.

FDA 510(k) clearance K930618 for VAGINAL CONTINENCE DEVICE, Substantially Equivalent on 1995-05-04. Applicant: Johnson & Johnson Medical, Inc..

Clearance details

Applicant: Johnson & Johnson Medical, Inc.
Product code: Code HHW
Advisory panel: Obstetrics/Gynecology
Date received: 1993-02-08
Decision date: 1995-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, 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.