# K961349: Injection Gold Probe

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 15, 1996 after 37 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- 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 K854238 (1985). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942301: Microvasive Injection Gold Probe, Boston Scientific Corp (1994) Summary page 3.

## Most influential descendants
- K110887: Injection Gold Probe Bipolar Electrohemostasis Catheter (2011), 4 descendants of its own
- K133933: Injection Gold Probe Bipolar Electrohemostasis Catheter (2014), 3 descendants of its own
- K171983: Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory (2017), 1 descendant of its own
- K232633: Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter (2023), 0 descendants of its own
- K192905: Creo Electrosurgical System with HS1 Hemostasis Accessory (2020), 0 descendants of its own

## Indications for use
The Modified Injection Gold Probe and Injection Gold Probe Direct are indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: peptic ulcers; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stocks; and angiomata. The Modified Injection Gold Probe and Injection Gold Probe Direct also have irrigation capability.

Source page: https://510kreport.com/device/K961349
Methodology: https://510kreport.com/methodology