# K003897: Endius Bipolar Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Mar 22, 2001 after 94 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
Longest line of descent: 1 generation back to K945975 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945975: Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps, Everest Medical Corp. (1994) Summary page 2.

## Indications for use
The Endius Bipolar Sheath is intended to be used to coagulate soft tissue during various spinal surgical procedures.

Source page: https://510kreport.com/device/K003897
Methodology: https://510kreport.com/methodology