# K211172: Single Use Electrosurgical Knife with Fluid Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Dec 17, 2021 after 242 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: 10 generations back to K952726 (1995). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193601: Single Use Electrosurgical Knife, Micro-Tech (Nanjing) Co., Ltd. (2020) Summary page 5.

## 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. The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

Source page: https://510kreport.com/device/K211172
Methodology: https://510kreport.com/methodology