# K101657: Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4 Hot Biopsy Forceps Box 40

- Pathway: 510(k) (Abbreviated)
- Applicant: Boston Scientific Corp
- Decided: Oct 5, 2010 after 116 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: 1 generation back to K910964 (1991). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910964: Hot Biopsy Forceps, Symbiosis Corp. (1991) Summary page 2.
- K955052: Olympus FD-1/2-1 Hot Biopsy Forceps, Olympus America, Inc. (1996) Summary page 2.

## Most influential descendants
- K212423: EndoDrill® Model X (2023), 1 descendant of its own
- K250187: Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (2025), 0 descendants of its own
- K231422: Precision GI (2023), 0 descendants of its own
- K131991: Endochoice Hot Biopsy Forceps (2013), 0 descendants of its own

## Indications for use
These Single-Use Biopsy Forceps are intended to be used through an endoscope to cauterize polyps and/or tissue specimens throughout the alimentary tract. The alimentary tract include the esophagus, stomach, duodenum, jejunum, ileum, and colon.

Source page: https://510kreport.com/device/K101657
Methodology: https://510kreport.com/methodology