HD-Camera HDC1000— 510(k) K152109

Name: FDA 510(k) clearance K152109
Creator: U.S. Food and Drug Administration
Published: 2015-10-13

Substantially Equivalent

W.O.M. World of Medicine GmbH

FDA 510(k) clearance K152109 for HD-Camera HDC1000, Substantially Equivalent on 2015-10-13. Applicant: W.O.M. World of Medicine GmbH. Device class: 2.

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Product code FET
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-07-29
Decision date: 2015-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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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.