# K152702: Ent Biotech Solutions Tissue Removal Device (Elasso)

- Pathway: 510(k) (Traditional)
- Applicant: Ent Biotech Solutions
- Decided: Feb 18, 2016 after 150 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: 13 generations back to K936109 (1994). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083415: Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device, Peak Surgical, Inc. (2009) Summary page 4.

## Indications for use
The ENT Biotech Solutions Tissue Removal Device (Elasso™) is intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including de-bulking adenoid and tonsil tissue (Pharyngeal, Tubal, and Palatine).

Source page: https://510kreport.com/device/K152702
Methodology: https://510kreport.com/methodology