DropSafe Safety Pen Needles— 510(k) K211716

Substantially Equivalent

Htl Strefa SA

FDA 510(k) clearance K211716 for DropSafe Safety Pen Needles, Substantially Equivalent on 2022-01-07. Applicant: Htl Strefa SA.

Clearance details

Applicant: Htl Strefa SA
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2021-06-03
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ozorków, PL

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.