HELIX HYDRO-JET— 510(k) K012464

Name: FDA 510(k) clearance K012464
Creator: U.S. Food and Drug Administration
Published: 2001-10-10

Substantially Equivalent

Andreas Pein Medizintechnik GmbH

FDA 510(k) clearance K012464 for HELIX HYDRO-JET, Substantially Equivalent on 2001-10-10. Applicant: Andreas Pein Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Andreas Pein Medizintechnik GmbH
Product code: Code FQH
Device class: Class 2
Regulation: 21 CFR 880.5475
Advisory panel: General Hospital
Date received: 2001-08-01
Decision date: 2001-10-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

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.