HYSTEROSCOPY SHEATH SET— 510(k) K903146

Substantially Equivalent

Cook, Inc.

FDA 510(k) clearance K903146 for HYSTEROSCOPY SHEATH SET, Substantially Equivalent on 1990-10-12. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1990-07-18
Decision date: 1990-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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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.