HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)— 510(k) K101547

Substantially Equivalent

Henke-Sass, Wolf GmbH

FDA 510(k) clearance K101547 for HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET), Substantially Equivalent on 2010-11-22. Applicant: Henke-Sass, Wolf GmbH.

Clearance details

Applicant: Henke-Sass, Wolf GmbH
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2010-06-03
Decision date: 2010-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Dora, FL, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.