# K012488: Modification to:Endius Bipolar Sheath

- Pathway: 510(k) (Special)
- Applicant: Endius, Inc.
- Decided: Aug 30, 2001 after 27 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 K981041 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981041: SLT Bipolar Sheath, Surgical Laser Technologies, Inc. (1998) Summary page 2.
- K984018: Hemosleeve, Model 4.0MM, 5.5MM, Surgical Laser Technologies, Inc. (1999) Summary page 2.

## Most influential descendants
- K083013: PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered Dissector Handpiece, Model 7033-9001 (2008), 0 descendants of its own

## 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/K012488
Methodology: https://510kreport.com/methodology