# K193601: Single Use Electrosurgical Knife

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Jul 24, 2020 after 214 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: 9 generations back to K952726 (1995). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171158: Single Use Electrosurgical knife, Olympus Medical Systems Corp. (2017) Summary page 5.

## Most influential descendants
- K211172: Single Use Electrosurgical Knife with Fluid Pump System (2021), 0 descendants of its own

## Indications for use
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

Source page: https://510kreport.com/device/K193601
Methodology: https://510kreport.com/methodology