# K212423: EndoDrill® Model X

- Pathway: 510(k) (Traditional)
- Applicant: Bibbinstruments AB
- Decided: Mar 29, 2023 after 602 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- 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.
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)
- 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 4.

## Most influential descendants
- K231422: Precision GI (2023), 0 descendants of its own

## Indications for use
The EndoDrill® Model X is intended to be used with an ultrasound endoscope for ultrasonically guided fine needle sampling of submucosal- and extramural lesions within gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses). This device is for diagnostic purposes only.

Source page: https://510kreport.com/device/K212423
Methodology: https://510kreport.com/methodology