Lubricity— 510(k) K163476

Substantially Equivalent

You First Services, Incorporated

FDA 510(k) clearance K163476 for Lubricity, Substantially Equivalent on 2017-05-10. Applicant: You First Services, Incorporated.

Clearance details

Applicant: You First Services, Incorporated
Product code: Code LFD
Advisory panel: Unknown
Date received: 2016-12-12
Decision date: 2017-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFD

product code LFD

Death: 3
Total: 3

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.