NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)— 510(k) K182387

Substantially Equivalent

Novo Nordisk, Inc.

FDA 510(k) clearance K182387 for NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector), Substantially Equivalent on 2018-12-17. Applicant: Novo Nordisk, Inc..

Clearance details

Applicant: Novo Nordisk, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2018-09-04
Decision date: 2018-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainsboro, NJ, 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.