# K984018: Hemosleeve, Model 4.0MM, 5.5MM

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Laser Technologies, Inc.
- Decided: Mar 15, 1999 after 123 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K992572: Ntero RF Sleeve (1999), 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
- K014251: Ntero Hotrod System (2002), 0 descendants of its own

## Indications for use
The SLT HemoSleeve Bipolar Sheath is indicated for use in general surgery procedures to provide coagulation at the distal end of a tissue debrider tip.

Source page: https://510kreport.com/device/K984018
Methodology: https://510kreport.com/methodology