KSEA SCBCOM— 510(k) K992469

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K992469 for KSEA SCBCOM, Substantially Equivalent on 1999-10-15. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1999-07-26
Decision date: 1999-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, 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.