CareSens Pen Needle, Softip Pen Needle— 510(k) K160575

Substantially Equivalent

Yidobio, Inc.

FDA 510(k) clearance K160575 for CareSens Pen Needle, Softip Pen Needle, Substantially Equivalent on 2016-09-07. Applicant: Yidobio, Inc..

Clearance details

Applicant: Yidobio, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2016-03-01
Decision date: 2016-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.