510(k) K082925— XENON-100 SCB LIGHT SOURCE, MODEL 20132620

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code GCT
Advisory panel: Gastroenterology, Urology
Date received: 2008-10-01
Decision date: 2008-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

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.