# K012864: Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 24, 2001 after 58 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: 1 generation back to K961846 (1996). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961846: Needle Catheter, Boston Scientific Corp (1996) Summary page 2.
- K971842: Coaxial Needle, United States Endoscopy Group, Inc. (1997) Summary page 2.
- (no number) Interject™ Injection Therapy Needle: named in the summary without a submission number

## Most influential descendants
- K171454: Interject Injection Therapy Needle Catheter (2017), 7 descendants of its own
- K190032: Disposable Sclerotherapy Needle (2020), 3 descendants of its own
- K220292: Disposable Endoscope Injection Needle (2022), 1 descendant of its own
- K212668: Sclerotherapy Needle (2022), 1 descendant of its own
- K241595: EzVu Visual Vasopressor injector (EV-19) (2025), 0 descendants of its own

## Indications for use
The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

Source page: https://510kreport.com/device/K012864
Methodology: https://510kreport.com/methodology