# K981041: SLT Bipolar Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Laser Technologies, Inc.
- Decided: Aug 27, 1998 after 160 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K012488: Modification to:Endius Bipolar Sheath (2001), 1 descendant of its own
- 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 SLT Bipolar Sheath is indicated for use with currently marketed debrider system tips used in Ear Nose and Throat Surgery. The SLT bipolar sheath is intended to provide coagulation of tissue at the distal end of the debrider tip. The sheath which incorporates the bipolar electrodes is designed with a standard interface to allow use with any electrosurgical system which meets the following requirements: Generator must operate in a Bipolar mode Generator must accept a standard banana plug connector and will fit on any debrider tips which meet the following requirements: Debrider tip must be either 3.5mm or 4.0mm in diameter

Source page: https://510kreport.com/device/K981041
Methodology: https://510kreport.com/methodology