HUMAPEN LUXURA HD— 510(k) K100988

Substantially Equivalent

Eli Lilly and Company

FDA 510(k) clearance K100988 for HUMAPEN LUXURA HD, Substantially Equivalent on 2010-08-17. Applicant: Eli Lilly and Company.

Clearance details

Applicant: Eli Lilly and Company
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2010-04-09
Decision date: 2010-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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.