# K942301: Microvasive Injection Gold Probe

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Nov 2, 1994 after 174 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: 1 generation back to K854238 (1985). 2 ancestors in all.
6 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)
- K885005: Microvasive Gold Probe, Boston Scientific Corp (1989) Summary page 4.
- K854238: Needle W/Stylet for Implantation, Microvasive (1985) Summary page 4.

## Most influential descendants
- K961349: Injection Gold Probe (1996), 5 descendants of its own
- 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

## Indications for use
The Microvasive Injection Gold Probe is indicated for use in endoscopic injection therapy and electrohemostasis of actual or potential bleeding sites in the gastrointestinal tract, including, but not limited to: the esophagus, stomach, duodenum, and colon. These sites include the following: peptic ulcers; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stalks; and angiomata.

Source page: https://510kreport.com/device/K942301
Methodology: https://510kreport.com/methodology