KARL STORZ MODEL 203020 20 EQUIMAT— 510(k) K961091

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K961091 for KARL STORZ MODEL 203020 20 EQUIMAT, Substantially Equivalent on 1996-10-03. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1996-03-19
Decision date: 1996-10-03
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.