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Dannik

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemMarch 12, 2025
K211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesOctober 28, 2021
K210569Disposable Monopolar Laparoscopic Shafts and Reusable HandlesAugust 16, 2021
K201063DANNIK Disposable Monopolar Laparoscopic InstrumentJune 9, 2020
K200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag OnApril 21, 2020
K193019DANNIK Disposable Monopolar Laparoscopic InstrumentMarch 4, 2020
K192711Dannik Titanium Ligation ClipDecember 20, 2019
K192643Dannik Laparoscopic Suction Irrigation SystemNovember 19, 2019