# K202438: Ensure Single-Use Coagulation Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Mar 15, 2021 after 202 days
- Product code: KGE (Forceps, Biopsy, Electric)
- Device class: 2
- Regulation: 21 CFR 876.4300
- 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 K955052 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062517: Electrosurgical Hemostatic Forceps Series, Olympus Medical Systems Corporation (2006) Summary page 5.

## Most influential descendants
- K251807: Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (2026), 0 descendants of its own

## Indications for use
These instruments have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

Source page: https://510kreport.com/device/K202438
Methodology: https://510kreport.com/methodology