# K971728: Pioneer Elec-Trocar Device

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Sep 19, 1997 after 133 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) Snyder Hemovac Round Drain with Trocar: named in the summary without a submission number
- (no number) Valleylab Footswitching Pencil: named in the summary without a submission number
- (no number) ConMed Trogard Universal Trocar: named in the summary without a submission number

## Indications for use
The device is used in general surgical procedures to place a wound drain by electrocautery action for extraction of serosanguineous fluid, blood, pus, or other bodily fluids.

Source page: https://510kreport.com/device/K971728
Methodology: https://510kreport.com/methodology