# K193019: DANNIK Disposable Monopolar Laparoscopic Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Dannik
- Decided: Mar 4, 2020 after 127 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910831 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 4.

## Most influential descendants
- K201063: DANNIK Disposable Monopolar Laparoscopic Instrument (2020), 0 descendants of its own

## Indications for use
The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.

Source page: https://510kreport.com/device/K193019
Methodology: https://510kreport.com/methodology