# K021046: Cobra Cooled Surgical Probe, Model 1596X

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 16, 2002 after 15 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Cobra® Surgical Probe: named in the summary without a submission number

## Indications for use
The Probe is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissues to produce hemostasis.

Source page: https://510kreport.com/device/K021046
Methodology: https://510kreport.com/methodology