# K961334: Heartport Handswitch Electrocautery Probe

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Nov 15, 1996 after 221 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) DLP (a division of Medtronic) - I.M.A. Electrocautery Knife Blades: named in the summary without a submission number
- (no number) Valleylab (a Pfizer company) - Disposable Handswitching Laparoscopic Handset and Laparoscopic Electrode: named in the summary without a submission number
- (no number) Ximed Medical Systems - Electroprobe Single-Use Surgical Probe: named in the summary without a submission number

## Indications for use
The Heartport Handswitch Electrocautery Probe is used in conjunction with standard electrosurgical generators for the hemostatic dissection of tissue and coagulation of blood. The long, narrow shaft allows the device to be used during the endoscopic takedown of the Internal Mammary Artery. The probe's central lumen allows for the evacuation of smoke generated by electrocautery as well as the removal of fluid from the thoracic cavity. The central lumen may also be used to provide irrigation fluid to the surgical site.

Source page: https://510kreport.com/device/K961334
Methodology: https://510kreport.com/methodology