KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE— 510(k) K961605

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K961605 for KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE, Substantially Equivalent on 1996-11-13. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1996-04-25
Decision date: 1996-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, 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.