Image1 SPIES System— 510(k) K160044

Substantially Equivalent

Karl Storz Endoscopy America, Inc.

FDA 510(k) clearance K160044 for Image1 SPIES System, Substantially Equivalent on 2016-02-01. Applicant: Karl Storz Endoscopy America, Inc..

Clearance details

Applicant: Karl Storz Endoscopy America, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2016-01-08
Decision date: 2016-02-01
Decision: Substantially Equivalent
Clearance type: Special
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.