# K211019: Disposable Monopolar Laparoscopic Tips and Reusable Handles

- Pathway: 510(k) (Traditional)
- Applicant: Dannik, LLC
- Decided: Oct 28, 2021 after 206 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: 5 generations back to K910831 (1991). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171825: Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument, Hunan Handlike Minimally Invasive Surgery Co., Ltd. (2018) Summary page 4.

## Indications for use
The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.

Source page: https://510kreport.com/device/K211019
Methodology: https://510kreport.com/methodology