INSTEAD, SOFTCUP— 510(k) K971303

Substantially Equivalent

Ultrafem, Inc.

FDA 510(k) clearance K971303 for INSTEAD, SOFTCUP, Substantially Equivalent on 1997-06-06. Applicant: Ultrafem, Inc..

Clearance details

Applicant: Ultrafem, Inc.
Product code: Code HHE
Advisory panel: Obstetrics/Gynecology
Date received: 1997-04-08
Decision date: 1997-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HHE

product code HHE

Injury: 344
Total: 344

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.