# K250187: Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Oct 7, 2025 after 258 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 K910964 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101657: Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4 Hot Biopsy Forceps Box 40, Boston Scientific Corp (2010) Summary page 5.

## Indications for use
The DISPOSABLE HOT BIOPSY FORCEPS FD-210U/FD-230U are intended to be used to collect tissue samples within the digestive tract using high-frequency current under endoscopic observation in combination with an endoscope.

Source page: https://510kreport.com/device/K250187
Methodology: https://510kreport.com/methodology