# K142022: Medline Renewal Reprocessed Gyrus-Diego Sinus Application Blades

- Pathway: 510(k) (Traditional)
- Applicant: Medline Renewal
- Decided: Dec 19, 2014 after 147 days
- Product code: NLY (Microdebrider, Ent, High Speed, Single Use, Reprocessed)
- Device class: 1
- Regulation: 21 CFR 874.4140
- 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 K020594 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020594: Diego Powered Dissector and Drill System, Gyrus Ent LLC (2002) Summary page 5.

## Indications for use
Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.

Source page: https://510kreport.com/device/K142022
Methodology: https://510kreport.com/methodology