KARL STORZ HYSTEROMAT II— 510(k) K000806

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K000806 for KARL STORZ HYSTEROMAT II, Substantially Equivalent on 2000-11-30. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2000-03-13
Decision date: 2000-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.