# K970278: Microvasive Gold Probe

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 11, 1997 after 78 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
No predicates in its family tree.
81 later devices descend from it; 7 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Microvasive Gold Probe: named in the summary without a submission number
- (no number) ACMI Bicap Tumor Probe: named in the summary without a submission number

## Most influential descendants
- K023765: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2002), 42 descendants of its own
- K013139: Stellartech Coagulation System (2001), 42 descendants of its own
- K032062: Stellartech Coagulation System, Models  (1100C-115 & 1100C-230) (2003), 41 descendants of its own
- K032452: Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 (2003), 39 descendants of its own
- K032721: Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) (2003), 38 descendants of its own

## Indications for use
The Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears, arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett’s Esophagus, angiodysplasia, and esophageal tumors.

Source page: https://510kreport.com/device/K970278
Methodology: https://510kreport.com/methodology