# K192128: Sutter Arrowtip Monopolar Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Sutter Medizintechnik GmbH
- Decided: Oct 4, 2019 after 58 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 K000348 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033232: Colorado Microdissection Needle, Stryker Corp. (2004) Summary page 4.

## Indications for use
The ARROWtip™ Single-Use monopolar electrode is an electrosurgical instrument for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The ARROWtip™ Single-Use monopolar electrode is not intended for use in the central nervous system or in the central circulatory system.

Source page: https://510kreport.com/device/K192128
Methodology: https://510kreport.com/methodology