# K201063: DANNIK Disposable Monopolar Laparoscopic Instrument

- Pathway: 510(k) (Special)
- Applicant: Dannik
- Decided: Jun 9, 2020 after 49 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: 3 generations back to K910831 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193019: DANNIK Disposable Monopolar Laparoscopic Instrument, Dannik (2020) Summary page 4.
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 4.

## 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/K201063
Methodology: https://510kreport.com/methodology