# K251807: Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 6, 2026 after 267 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: 3 generations back to K955052 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202438: Ensure Single-Use Coagulation Forceps, Micro-Tech (Nanjing) Co., Ltd. (2021) Summary page 5.

## Indications for use
Models FD-410LR & FD-412LR: The Single Use Electrosurgical Hemostatic Forceps FD-410LR/412LR are intended to be used to cauterize and coagulate or perform hemostasis using high-frequency current within the upper digestive tract in combination with an endoscope. Model FD-411UR: The Single Use Electrosurgical Hemostatic Forceps FD-411UR is intended to be used to cauterize and coagulate or perform hemostasis using high-frequency current within the lower digestive tract in combination with an endoscope.

Source page: https://510kreport.com/device/K251807
Methodology: https://510kreport.com/methodology