FEMRX OPERASTAR SYSTEM— 510(k) K954648

Substantially Equivalent

Gynecare Innovation Center

FDA 510(k) clearance K954648 for FEMRX OPERASTAR SYSTEM, Substantially Equivalent on 1996-03-14. Applicant: Gynecare Innovation Center.

Clearance details

Applicant: Gynecare Innovation Center
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1995-10-10
Decision date: 1996-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.