POWER LED 175— 510(k) K123956

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K123956 for POWER LED 175, Substantially Equivalent on 2013-01-25. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FCW
Advisory panel: Gastroenterology, Urology
Date received: 2012-12-21
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.