IMAGE1 SPIES— 510(k) K131953

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K131953 for IMAGE1 SPIES, Substantially Equivalent on 2013-12-20. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-27
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.