EBERLE Shaver System C3 and Accessories— 510(k) K193608

Substantially Equivalent

Eberle GmbH & Co. KG

FDA 510(k) clearance K193608 for EBERLE Shaver System C3 and Accessories, Substantially Equivalent on 2021-01-15. Applicant: Eberle GmbH & Co. KG.

Clearance details

Applicant: Eberle GmbH & Co. KG
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2019-12-26
Decision date: 2021-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wurmberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.