Chrysalis Intelligence · Sponsors · Htl-Strefa S.A

Htl-Strefa S.A

Ozorkow, PL · 4 510(k) clearances

Total clearances
4
2020-04-21 → 2025-07-01
Last 12 months
0
Product codes
3
Most recent
2025-07-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FMI Needle, Hypodermic, Single Lumen Class II General Hospital 2 2020-10-15
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature Class II General, Plastic Surgery 1 2025-07-01
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Class II General, Plastic Surgery 1 2022-07-08
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-07-01 K250016 droplet® personal lancets QRK Class II General, Plastic Surgery
2022-07-08 K220643 DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets FMK Class II General, Plastic Surgery
2020-10-15 K202340 Droplet Pen Needle 30G & 33G FMI Class II General Hospital
2020-04-21 K192082 Droplet Pen Needle 34G FMI Class II General Hospital