DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)— 510(k) K910254

Unknown

CooperSurgical, Inc.

FDA 510(k) clearance K910254 for DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM), Unknown on 1991-04-18. Applicant: CooperSurgical, Inc..

Clearance details

Applicant: CooperSurgical, Inc.
Product code: Code HHE
Advisory panel: Obstetrics/Gynecology
Date received: 1991-01-22
Decision date: 1991-04-18
Decision: Unknown
Clearance type: Traditional
Location: Mountain View, CA, US

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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.