# K232633: Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Nov 28, 2023 after 90 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: 5 generations back to K854238 (1985). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970278: Microvasive Gold Probe, Boston Scientific Corp (1997) Summary page 5.
- K123319: Gyrus Acmi Bicoag Hemostasis Probe, Olympus Surgical Technologies America (2012) Summary page 6.
- K133933: Injection Gold Probe Bipolar Electrohemostasis Catheter, Boston Scientific Corporation (2014) Summary page 6.

## Indications for use
Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in transendoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. Injection Gold Probe Bipolar Electrohemostasis Catheter is 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. The Injection Gold Probe Catheter also has irrigation capability. Any other use is not recommended.

Source page: https://510kreport.com/device/K232633
Methodology: https://510kreport.com/methodology