# K972865: Promex Ent Tissue Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Sep 29, 1997 after 56 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K161307: NICO Myriad (2016), 4 descendants of its own
- K182340: NICO Myriad (2018), 1 descendant of its own
- K180372: Aurora Evacuator (2018), 1 descendant of its own
- K191599: NICO Myriad NOVUS (2019), 0 descendants of its own
- K190075: Aurora Evacuator (2019), 0 descendants of its own

## Indications for use
For the removal of soft tissue and bone in the ear, nose & throat.

Source page: https://510kreport.com/device/K972865
Methodology: https://510kreport.com/methodology