KSEA DION-GRACIA SET— 510(k) K010785

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K010785 for KSEA DION-GRACIA SET, Substantially Equivalent on 2001-08-21. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2001-03-15
Decision date: 2001-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.