Genteel Lancing Device— 510(k) K153670

Substantially Equivalent

Genteel, LLC

FDA 510(k) clearance K153670 for Genteel Lancing Device, Substantially Equivalent on 2016-05-12. Applicant: Genteel, LLC.

Clearance details

Applicant: Genteel, LLC
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 2015-12-21
Decision date: 2016-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midland, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.